Professor Anneke Lucassen contributes to report on the safety and efficacy of mitochondrial replacement techniques

The report was published on 3 June by the HFEA recommending that mitochondrial replacement techniques be considered ‘not unsafe’ for use on a ‘specific and defined group of patients’. The topic was also covered in an interview on BBCR4 Today programme with one of the panel members on 4 June and led to an article published by the BBC .

The report concluded that mitochondrial replacement techniques are potentially useful for a specific group of patients: those wishing to have their own genetically-related child, but whose offspring are at risk of severe or lethal genetic disease, due to mutations in the mitochondrial DNA.

In February 2014, the Government launched a consultation on draft regulations for the use of MR techniques - Maternal Spindle Transfer (MST) and Pronuclear Transfer (PNT) - to prevent mothers passing on serious mitochondrial diseases. Such treatments have not been carried out anywhere in the world and are currently illegal in the UK.

As part of the consultation, the Department of Health requested that the HFEA reconvene its Expert Panel to examine the safety and effectiveness of these techniques. This was the third review, with similar undertakings being carried out by panels in 2011 and 2013. The review was commissioned by the Government to contribute towards a decision on whether such techniques should be made legal.

The Panel was comprised of experts, including Southampton’s Professor Lucassen , with broad-ranging scientific and clinical expertise, who considered the evidence contained in 17 different submissions sent from scientists in the UK and abroad over the course of three Panel sessions.

The HFEA has produced a report outlining the Panel’s findings and recommendations to Government. It states that: The panel is of the view that the techniques of MST and PNT are potentially useful for a specific and defined group of patients: those wishing to have their own genetically-related child, but whose offspring are at risk of severe or lethal genetic disease, due to mutations in the mitochondrial DNA [mtDNA] which the mother carries.

At each stage of the review process the panel reached a view that the evidence it has seen does not suggest that these techniques are unsafe.

However, there are still experiments – some critical, some desirable - that need to be completed before clinical treatment should be offered.

Sally Cheshire, Chair of the HFEA, praised the open-minded process undertaken by the Panel, concluding that it is now for Government to decide the next step.
‘This scientific review is our third in three years and I am grateful to our panel of experts for the rigour of their work. The review process has assembled an evidence base on the safety and efficacy of these two mitochondrial replacement techniques which stands comparison with anything published in the UK or abroad.
‘The science is complex, but the aim is simple: to enable mothers to not pass on to their children a range of serious, and sometimes fatal, inherited conditions. In all of our discussions we should not lose sight of this.
‘Now it is a question for others. If the Government decides to seek to change the law they will need the approval of both Houses of Parliament, and it is only right that they consider all the ramifications, social as well as medical, before they make up their minds. There is a long way to go yet.’

Panel Chair, Dr Andy Greenfield said:
‘This review has been a demanding process for all involved. Perhaps the greatest challenge was the breadth of data that needed to be considered.
‘The Panel has examined, discussed and re-examined data from disparate fields of science, including biochemistry, evolutionary biology, the genetics and developmental biology of model organisms and, of course, clinical genetics and embryology. We believe that our recommendations are firmly based on the data that we examined.’

Panel member, Professor Lucassen said:
“As a clinician I have met women with mitochondrial conditions who know that each child they have will inherit the condition from them. These techniques have the potential to offer great hope to a select group of families”.

View the full report.
PRESS RELEASE ADAPTED FROM RELEASE ISSUED BY HFEA.GOV.UK