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expert reaction to HFEA’s third scientific review into safety and efficacy of mitochondria replacement

The Human Fertilisation and Embryology Authority (HFEA) was asked by government to reconvene its core panel of experts to review the latest evidence on the safety and efficacy of mitochondrial donation techniques, recommending that they be considered ‘not unsafe’ for use on a ‘specific and defined group of patients’. These comments accompanied a press briefing.


Prof Frances Flinter, Consultant in Clinical Genetics at Guy’s and member of the Nuffield Council working party on mitochondrial replacement therapies, said: 

“Patients who are affected by serious mitochondrial disorders will welcome the latest review from the HFEA, which has found no evidence that proposed new therapies to treat these conditions are unsafe. If the law is changed to allow mitochondrial replacement therapy it will be essential that couples considering treatment as part of a clinical trial are counselled very carefully beforehand, both about the potential risks and benefits of such therapies and also the importance of long term follow-up of any children that are born as a result.”


Alastair Kent, Director, Genetic Alliance UK, said:

“Here is another clear signal that we are nearing the level of evidence that will be sufficient to bring mitochondrial donation to families in the UK affected by mitochondrial DNA conditions. This increases the urgency to finalise the regulations to permit the use of this technology that were the subject of a recent consultation. We should be waiting for the science to be ready, not for the regulations, and the science is moving quickly.”


Robert Meadowcroft, Chief Executive of the Muscular Dystrophy Campaign, said:

“We must ensure there is a thorough examination of risk before any new potential treatment moves forward into clinical trials. This latest review follows those that took place in 2011 and 2013, and examines the most recent findings of ongoing research to further develop mitochondrial donation IVF. It is encouraging that the HFEA finds no evidence that the techniques could be unsafe.

There is currently no effective treatment available for mitochondrial diseases, and at this time, prevention remains our strongest option. By taking steps to progress mitochondrial donation IVF research forward into the clinic, we can move towards giving women living with these devastating and unpredictable conditions the choice to bear their own unaffected children.”


Sarah Norcross, Director of the Progress Educational Trust, said:

“The committee has found the proposed techniques to avoid passing on mitochondrial disease “not unsafe”. That is as good as it gets for this type of novel technique in reproductive medicine.

There is nothing in this third scientific review to prevent the Government passing legislation to allow these treatments to be used in the clinic, and so we hope it is third time lucky for families affected by mitochondrial disease. The findings of this review should mean that affected families are a step closer to being able to avoid passing on these debilitating diseases.”


Dr Jeremy Farrar, Director of the Wellcome Trust, said:

“We are extremely pleased that the latest scientific review of mitochondrial donation techniques has confirmed that there is no evidence to suggest either technique is unsafe, and that both could help families affected by serious mitochondrial disease. As the review concludes, it is never possible to answer every safety question before new medical procedures are used in people, but the scientific evidence suggests that any risks of mitochondrial transfer are proportionate to the severity of the condition and the potential benefits for patients. Given this evidence, we urge Parliament to pass enabling regulations swiftly, to ensure that there is no delay in patients being able to access these life-changing techniques.”


‘Third scientific review of the safety and efficacy of methods to avoid mitochondrial disease through assisted conception: 2014 update’ by Greenfield et al. published on on Tuesday 3rd June 2014.


Declared interests

Prof Frances Flinter: “I see patients who might benefit from these treatments in my clinic, and was a member of the Nuffield Council’s working party. I am also involved in offering PGD, but our department does not plan to offer mitochondrial replacement therapy at this stage.”

Alastair Kent: “I am employed by Genetic Alliance UK, the national charity working to improve the lives of patients and families affected by all types of genetic conditions. We are an alliance of over 160 patient organisations. Our aim is to ensure that high quality services, information and support are provided to all who need them. We actively support research and innovation across the field of genetic medicine.

Policy and practice in generating resources to support the work of Genetic Alliance UK (including that carried out as part of our projects SWAN UK and Rare Disease UK) is determined by the Trustee Board of the Charity, the members of which are nominated and elected by the patient organisations which comprise Genetic Alliance UK’s membership.

Having determined a strategy and a work plan Genetic Alliance UK then seeks resources to implement it from a wide range of potential funders including National Governments, the EU, the pharmaceutical and medical devices industry, the Medical Research Council, Wellcome Trust, The Big Lottery and others. Patient organisations also pay a subscription according to their size. Genetic Alliance UK does not accept unsolicited grants that are contingent on the organisation carrying out work on behalf of a third party that would be counter to the interests of patients and families with genetic disorders or which would hinder the effective delivery of the strategy endorsed by the Trustee Board.

Full details of our funding policy can be found here:

All our income is reported in our annual reports available here:

I am invited to speak at a wide range of conferences and meetings on issues arising from my role as director of Genetic Alliance UK, the expenses for which are met directly or reimbursed to me by the organisers. These include public, private and voluntary sector bodies in the UK and internationally. I am also the Chair of the UK Rare Diseases Forum, the body set up by the four health ministers of the UK to monitor implementation of the UK Strategy for Rare Diseases and to report on progress every two years, and a member of NHS England’s Rare Disease Advisory Group.”

Robert Meadowcroft: “The Muscular Dystrophy Campaign does not have a financial interest in mitochondrial research.  We have been a long-term funder of research into mitochondrial disease, conducted by Professor Doug Turnbull and his team at Newcastle University.  Professor Turnbull was appointed a Vice President of the Muscular Dystrophy Campaign in 2013, an honorary position which carries no payment or reward.”

Progress Educational Trust (PET) receives some grant funding from the Wellcome Trust and Medical Research Council but it is not directly related to work in this area.

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