March 20, 2013

expert reaction to announcement of HFEA advice to Government on mitochondrial replacement

On Wednesday 20 March the Human Fertilisation and Embryology Authority (HFEA) presented to the Government the findings from their public consultation on new IVF-based treatments to avoid mitochondrial disease, and whether these techniques should be made available in the UK.

Professor Sir John Tooke, President of the Academy of Medical Sciences, said:

“We are delighted that a recent public dialogue has shown broad public support for permitting mitochondria replacement to prevent transmission of serious mitochondrial disease.

“It is vital that therapies which could reduce the number of children born with rare mitochondrial diseases receive the support and guidance that will see research translated to patient benefits as quickly and safely as possible.

“Given the broad public support and the advice from the HFEA we urge the Government to make changes to the legislation so that these techniques can be used in the clinic, provided that further research continues to demonstrate their safety and efficacy.”

Hugh Whittall, Director of the Nuffield Council on Bioethics, said:

“In its 2012 report the Council concluded that the two new techniques represent an ethically acceptable treatment option for families affected by mitochondrial disorders, provided further research shows they are likely to be sufficiently safe and effective, and that families are offered appropriate information and support. Any treatment would need to be provided under strict regulation, and long term follow up of any children born via this method would be crucial. 

“Given that only some elements of the donor egg are used, not including the cell nucleus, we have taken the view that mitochondria donors should not be treated in the same way as egg donors for IVF, for example, they should not be required later to be identifiable to those born from their donation.

“The Council concluded that the proposed treatments would be a form of germline therapy, as changes resulting from the replacement of mitochondrial DNA would be passed on to the descendants of any girls born from the techniques. However, there is a clear line between these particular techniques and germline therapies that would act on the nuclear genome. These would involve further ethical considerations and would need to be considered entirely separately.”

Ted Bianco, Acting Director of the Wellcome Trust, said:

“This report shows that the public is broadly in support of this research because of its potential to provide families with a history of mitochondria disease with the opportunity to have healthy children. Enabling the new techniques to be adopted by clinics as soon as the safety and effectiveness research has been completed should be a priority for legislative changes being considered by the Government in the term of this Parliament.”

Prof Doug Turnbull, Professor of Neurology and Director of the Wellcome Trust Centre for Mitochondrial Research at Newcastle University, said:

“Mitochondrial DNA disease runs in families and there is no cure. The techniques we are working on here in Newcastle, could help hundreds of women have healthy children.

“We are very grateful for the detailed public engagement exercise carried out by the HFEA and welcome the supportive views of most of the public.

“We understand that more research is required but believe it is crucial that the Government moves now to draft the regulations so that mitochondrial patients in the UK will have access to this treatment.”

Prof Mary Herbert, Professor of Reproductive Biology at Newcastle University, said: 

“We are currently working towards refining and perfecting the techniques with the aim of providing a safe and effective treatment to reduce the risk of mitochondrial DNA disease in the children of affected families.  It is really important that the regulatory and legal process required to permit the use of these techniques in clinical practice is progressed in parallel with the science”

Prof Alison Murdoch, Honorary Professor of Reproductive Medicine at Newcastle University, said:

“The next step is for Government to draft the regulations needed under the Human Fertility and Embryology Act so that an application can, when appropriate, be submitted to the HFEA to permit treatment.

“We welcome the HFEA’s recommendation that mitochondria donors should be thought of as tissue donors, protecting the anonymity of the donor.

“Although further discussions will be needed, we believe that the Reports submitted today are a very positive step towards achieving suitable oversight for these new treatments.”

Dr Marita Pohlschmidt, Director of Research at the Muscular Dystrophy Campaign, said:

“We welcome these recommendations. There is currently no effective treatment available for mitochondrial diseases, and at this time, prevention remains our strongest option. By taking forward research into pro nuclear IVF, we move towards giving women living with these devastating and unpredictable conditions the choice to bear their own unaffected children. This technique does involve a step into new scientific territory. But it is a calculated, specific step with the sole aim of preventing a potential fatal condition from being passed down to the next generation, where possible.

“We respect that this is complex issue that generates strong views both in support and opposition. The HFEA’s consultation has been a crucial opportunity to share the realities of this IVF technique with the public, and to create open, transparent dialogue. We, and the families we work with, are grateful it has received the backing needed to move forward.

“The HFEA assures us that its recommendations will be made to the Secretary of State for Health by Easter. It has taken years to reach this stage – keeping up momentum now is vital. The Government must decide swiftly on whether regulations will go to vote in both Houses of Parliament.”