Mitochondrial replacement therapy approval
22 Jul 2014
Government plans to legalise the use of new techniques to prevent mothers passing on serious mitochondrial diseases to their children are set to progress.
According to the Department of Health, roughly one in 6,500 children are born every year in the UK with a serious mitochondrial DNA disorder.
Mitochondrial disease is passed from mother to child through faults in the mitochondrial DNA, and can cause the premature death of children, long-term ill-health and low quality of life.
Following a consultation on proposed new regulations which resulted in more than 1800 responses, government has agreed to the following:
- It will keep the definition of the mitochondrial donation techniques as they are set out in the draft proposals
- It will continue with plans that the Human Fertilisation and Embryology Authority (HFEA) would have to be satisfied that there is both a particular risk of mitochondrial abnormality and a significant risk the person will develop a serious illness or condition
- HFEA will consider each application on a case-by-case basis
- Only non-identifying information about the mitochondrial donor will be released to people born following mitochondrial donation when they reach age 16
- Clarification will be given to the consent requirements around the use and storage of eggs and embryos used in the mitochondrial donation techniques
- Further consider the recommendations of the expert panel, refine the draft regulations to take account of changes identified during the consultation, and discuss with the HFEA an appropriate approval process
Though today’s announcement has been well received, there is some disappointment at the time it took government to reach this point.
Sarah Norcross, director of the Progress Educational Trust, said: “A year ago, the government promised a consultation in autumn 2013 which ultimately took place in March 2014. We note that the government now aims to provide an update by early autumn 2014 - we hope that this is not similarly delayed, and that these regulations are brought before parliament at the earliest opportunity.”
Likewise, director of the Wellcome Trust Jeremy Farrar said: “There is now no excuse for the government not to table regulations for debate as soon as parliament returns this autumn, so that the HFEA can licence clinics to treat affected families without delay once it is satisfied that any risks are acceptable.”
