The HFEA has approved a licence application for Newcastle University to use mitochondrial donation therapy in treating mitochondrial disease.
Mr James Lawford Davies, Partner, Hempsons, said:
“This marks the end of a remarkable 13 year journey for the Newcastle team who have persevered through litigation, public consultations, Parliamentary debates, and intense ethical and scientific scrutiny. Their determination to offer this opportunity to their patients, whilst maintaining public and political support for their research, makes this a particularly welcome outcome.”
Robert Meadowcroft, Chief Executive at Muscular Dystrophy UK, said:
“This is wonderful news for the many women we know who have faced heartbreak while trying to start their own family. As with many pioneering advances, success can’t yet be 100 percent guaranteed, but today is a happy day for some 2,500 women in the UK who could benefit from mitochondrial donation IVF. Newcastle was where we first funded Prof Sir Doug Turnbull and his research in this field more than ten years ago, and so there couldn’t be a better place for this technique to be trialled. We eagerly await news of the first children in the UK to be born free of this serious, debilitating condition.”
Dr Meenakshi Choudhary, Consultant Gynaecologist & Sub Specialist in Reproductive Medicine, HFEA Person Responsible for Research, and Mitochondrial donor program lead, Newcastle Fertility Centre, said:
“We at Newcastle Fertility Centre at Life, are delighted with the announcement today by HFEA approving our licence application for offering mitochondrial donation option to women suffering with serious mitochondrial diseases to give them a chance to have a healthy baby free of this condition and prevent transmission.
“This announcement gives a hope and silver lining as we all strive together to help these women. Women of the northeast who donated their eggs for the pre-clinical research deserve a special mention, without whom we would not have been able to see it reach this milestone.
“Moving forward, we urge women who are considering donating their eggs for mitochondrial donation treatments to get in touch with us for further information and counseling.
“We are optimistic of working collaboratively to be able to lead this successfully to fruition.”
Sally Cheshire, HFEA Chair, said:
“I can confirm today that the HFEA has approved the first application by Newcastle Fertility at Life for the use of mitochondrial donation to treat patients.
“This significant decision represents the culmination of many years hard work by researchers, clinical experts, and regulators, who collectively paved the way for Parliament to change the law in 2015 to permit the use of such techniques.
“Patients will now be able to apply individually to the HFEA to undergo mitochondrial donation treatment at Newcastle, which will be life-changing for them, as they seek to avoid passing on serious genetic diseases to future generations.”
Dr Jeremy Farrar, Director of Wellcome said:
“Today’s decision means that affected couples in the UK who have dreamt of having a baby free of mitochondrial disease will have an option open to them for the first time. This is the latest step in a ten year process which started with laboratory science at the Wellcome Centre for Mitochondrial Research at Newcastle University.
“From the first proof of concept studies to today, there has been an excellent, independent regulatory process which consulted patients and the public at every stage.
“Now, we must give the first patients and their doctors the time and space to discuss the next steps with the patience, sensitivity and scientific rigour that they have displayed throughout.”
Prof Adam Balen, Chair of the British Fertility Society (BFS):
“HFEA’s decision to grant the Newcastle Fertility Centre at Life a licence to offer mitochondrial donation marks a historical step toward eradicating genetic diseases. Scientists in Newcastle have led the way on this groundbreaking research which will help families to overcome mitochondrial disease.
“Mitochondrial DNA is only inherited from mothers and women can be at risk of passing this DNA onto their children. Preventing this transmission by using eggs donated from a healthy woman will allow women carrying the mutations to give birth to children free of the disease.”
Alastair Kent, Director, Genetic Alliance UK, said:
“We are now at a very exciting point in what has been a long deliberative process. With funding and a licence in place, women at risk of having a child affected by a condition caused by a mitochondrial DNA mutation can now access this innovative technique.
“This is a welcome new reproductive choice tool for families affected by rare genetic conditions to take control of their futures. We wish the Newcastle team the best and hope they will be afforded appropriate space and time to begin their clinical process.
“Praise is due to the HFEA who have worked to minimise delays in access to this treatment by carrying out their rigourous licensing process efficiently.”
Hugh Whittall, Director, Nuffield Council on Bioethics said:
“This is an important step forward for families at risk of passing on severe mitochondrial disorders. We are pleased to note that the licensing of this treatment reflects the recommendations of our 2012 report which concluded that if it proceeds it should be carried out in a research environment with documented processes for monitoring children born as a result. It is important that this all takes place within the strong regulatory framework that we have in the UK.”
Prof. Mary Herbert, Professor of Reproductive Biology, Newcastle Fertility Centre and Newcastle University, said:
“The team here at Newcastle Fertility Centre is delighted with the HFEA’s decision to grant our clinic a licence to offer treatments to prevent transmission of mitochondrial DNA disease.
“Many years of research have led to the development of pronuclear transfer as a treatment to reduce the risk of mothers transmitting disease to their children.
“It’s a great testament to the regulatory system here in the UK that research innovation can be applied in treatment to help families affected by these devastating diseases.”
Prof. Doug Turnbull, Director of the Wellcome Centre for Mitochondrial research at Newcastle University said:
“I am delighted for patients as this will allow women with mitochondria DNA mutations the opportunity for more reproductive choice.
“Mitochondria diseases can be devastating for families affected and this is a momentous day for patients who have tirelessly campaigned for this decision.”
Prof. Allan Pacey, Fertility Expert at the University of Sheffield, said:
“This is very good news and a great day for science. I’d like to congratulate the team in Newcastle for their hard work in getting to this stage and I wish them every success in applying this technology to the first UK patients. This is a tremendous example of what can happen if scientists, clinicians, parliamentarians, regulators and patient support groups all work together for a common aim.”
Prof. Simon Fishel, Founder, President and Head of R&D at CARE Fertility, said:
“This is excellent news, especially for those patients in the UK who have been waiting for this opportunity. We know it won’t be easy for all concerned as the technology is not straight forward and success will depend upon many factors. But it is indeed a step in the right direction following in-depth debate and consideration of all issues from the medical science to the ethics. Regulating this technology via the HFEA and providing the opportunity for couples to deliver children free of this devastating disease here in the UK is a milestone that all who care about medical health will welcome, and we wish the Newcastle team and their patients a very successful programme.”
All our previous output on this subject can be seen at this weblink: http://www.sciencemediacentre.org/tag/mitochondrial-dna/
James Lawford Davies: James Lawford Davies is a Partner at Hempsons Solicitors, a Director of the Campaign for Science and Engineering, and a Director of the London Regenerative Medicine Network. He also advised Newcastle University in relation to this research.
Dr Meenakshi Choudhary: “I am part of the Newcastle team who submitted the license application and is the lead for mitochondrial donor program.”
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: http://www.geneticalliance.org.uk/ethicalcollaborationpolicy.htm
All our income is reported in our annual reports available here: http://www.geneticalliance.org.uk/annual-report.htm
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.
Prof Mary Herbert: M.Herbert is employed by Newcastle University as Professor of Reproductive Medicine based at Newcastle Fertility and Wellcome Trust Centre for Mitochondrial Research.
Prof Doug Turnbull: Prof Doug Turnbull receives funding from the Wellcome Trust for research into mitochondrial donation techniques and other research into mitochondrial disease. His other research is supported by MRC, BBSRC and NHIR.
Prof. Allan Pacey: “Chairman of the advisory committee of the UK National External Quality Assurance Schemes in Andrology, Editor in Chief of Human Fertility and Trustee of the Progress Educational Trust (all unpaid). Also, recent work for the World Health Organisation, British Broadcasting Corporation, Purple Orchid Pharma (paid consultancy with all monies going to University of Sheffield). Co-applicant on a research grant from the Medical Research Council (ref: MR/M010473/1).”
Prof. Simon Fishel: “I am employed by and a shareholder in CARE Fertility.”
None others received.