February 24, 2015

expert reaction to House of Lords parliamentary vote on mitochondrial donation

The House of Lords has voted in favour of the new regulations concerning mitochondrial donation techniques.

Professor Graeme Laurie, Founding Director of the JK Mason Institute for Medicine, Life Sciences and the Law at the University of Edinburgh, said:

“This is a triumph for responsible Parliamentary debate and sound scientific progress. It is scientific folly to talk about three-parent babies and profoundly ethically misleading. Westminster has seen through the scaremongering and approved a technique that will now be responsibly regulated by the most experienced regulator in the world: the Human Fertilisation and Embryology Authority. The real ethical issues to be explored are that the technique is safe and effective, and that donors and prospective parents receive appropriate information and counselling. Longer-term follow-up will also be crucial to monitor the benefits and downstream implications, but this is a crucial and responsible first step that will bring hope to many people.”

Prof. Doug Turnbull, Professor of Neurology, Newcastle University, said:

“This is wonderful news for patients and families affected by mitochondrial disease. Mitochondrial donation has undergone essential scientific, ethical and parliamentary scrutiny. I am delighted that the House of Lords supported the regulations with such enthusiasm.”

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

“Families who know what it is like to care for a child with a devastating disease are the people best placed to decide whether mitochondrial donation is the right option for them. Parliament is to be commended for a considered and compassionate decision to give these families that choice, with proper safeguards under the UK’s internationally-admired regulatory system.

“Parliament’s decision is a credit to the patients, scientists, doctors and ethicists who have worked so hard over the past decade to explain this complex research to politicians, the public and the media, and to the exemplary process for reviewing scientific, ethical and public opinion led by the Human Fertilisation and Embryology Authority. We have again seen how science advances most effectively through engagement with wider society.”

Mr Alastair Kent OBE, Director of Genetic Alliance UK, said:

“Today’s vote in the House of Lords is a triumph that gives hope to families who otherwise would have to face the prospect of not being able to conceive a child free from a life limiting disease.

“With this vote the Human Fertilisation and Embryology Authority is empowered to licence the use of mitochondrial donation. We look forward to working with the HFEA and our members to ensure the voice of those families that stand to benefit is considered as part of the licensing process, so that when the time is right, they can look forward to children of their own who will not be affected by serious mitochondrial disease.”

Dr Mark Downs, Chief Executive of the Society of Biology, said:

“This is a great day for UK science and for many families affected by incurable mitochondrial diseases. This landmark decision will ensure mothers who carry faulty mitochondria can have healthy children free from the devastating conditions caused by these particular defects. We fully support the introduction of regulations which will facilitate treatment while carefully monitoring outcomes.”

Dr David J Clancy, Lecturer researching genetics and biology of ageing, Lancaster University, said:

“This is a very difficult area indeed. I think that the science is sufficiently clear that, if the procedure proceeds on any sort of scale, at some point a human will be created with mismatched mitochondrial and nuclear genomes such that their life is shortened by it. Incidentally, it will be more likely to be male.  Much of the science behind this comes from the fruit fly Drosophila and it was brought to the HFEA who, wrongly in my view, mostly dismissed it as being not generally applicable to humans.

‘….. in 2013 the panel maintained the view that there is no evidence for any mismatch between the nucleus and any mtDNA haplogroup, at least within a species.’
‘The panel also suggested that more extensive studies on Drosophila from outbred genetic backgrounds may be beneficial in determining the relevance of the fly model to humans, given that the latter are generally both outbred and where interbreeding is common.’

“Unfortunately the panel was unaware of existing evidence, of exactly the sort they recommended be undertaken, in a paper they had been referred to and cited in their report, which showed large negative effects on lifespan of nuclear-mitochondrial mismatches ( this was some of my own work).

“However the panel did recommend that ‘consideration is given to mtDNA haplogroup matching when selecting donors, although the panel considers that the risks of not doing so will be very low, and that there may be practical factors preventing it.’ They did not elaborate on how this might be done.

“It is a difficult area because, without any attempts at genome matching, the likelihood of producing a genetically unfit individual using this reproductive technology must be traded off against the benefits to the carriers of mitochondrial diseases in being able to produce children who bear half of their chromosomes. It could be argued that donor IVF runs a similar risk of genetic incompatibilities, but that is not a good argument. If we are OK with the risk-benefit equation, that’s fine, but while the benefits are clear and fairly simple, the risks should be properly apprehended. It is unclear to me whether they are.

“A ‘best effort’ might require that the donor mitochondria have the same genotype as that of the father. In that way we might have some expectation that the donor mtDNA be somewhat compatible with at least half of the child’s genome.”

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

“We must congratulate both MPs and Peers for their commitment to this fiercely debated issue, and for recognising the compelling reasons for moving forward with mitochondrial donation IVF. This result will be life-changing for many women living with mitochondrial disease, giving them the precious chance to bear unaffected children, removing the condition from a family line and reducing the numbers faced with its devastating effects.

“We hope to see a change in the law by the Autumn so that these women can benefit from this treatment. Families have waited through years of thorough ethical, safety and public reviews to reach where we are today. This is a monumental moment in the search for treatments and cures for people affected by this condition.”

Prof. Frances Flinter, Consultant in Clinical Genetics at Guy’s & St Thomas Hospital said:

“I am delighted that the House of Lords has approved new regulations that will allow scientists to apply to the HFEA for a licence to treat previously untreatable, serious mitochondrial disorders. This is wonderful news for families affected by these conditions as it gives them, for the first time, the hope that they may one day be able to have a healthy baby. The strict regulatory framework that exists in the UK, together with our internationally renowned scientific expertise, makes this country the best place in the world to develop these ground-breaking techniques.”

Ms Sarah Norcross, Director of the Progress Educational Trust (PET), said:

“Since before the birth of Louise Brown, the UK has led the world in fertility treatment and embryo research. Today’s vote will enable the latest research in this area to be carried forward, to treat women who are at risk of passing on mitochondrial disease to their children. This is a victory for reproductive choice – the people best placed to decide whether mitochondrial donation is the right option are the families who stand to benefit, in consultation with their clinicians.”

Prof. Robert Lightowlers, Director of Institute for Cell and Molecular Biosciences and Professor of Molecular Neuroscience, Newcastle University, said:

“It is so pleasing to see that the Lords have been persuaded by the large body of data in support of mitochondrial donation that has accrued over the past seven or so years. It is again a major victory for choice and for the families who may benefit from this procedure. The final decision for regulation of this process will now fall to the HFEA.”

Prof. Alison Murdoch, Head of Newcastle Fertility Centre at Life, Newcastle University, said:

“For 10 years we have publically discussed mitochondrial donation to explain how it could help patients whose families are blighted by the consequences of mitochondrial abnormalities. Whilst acknowledging the views of those who have a fundamental objection to our work, Parliament has determined that we should continue. We hope that opponents will accept its democratic decision.

The science will be reviewed and, if accepted, we hope to be able to submit a treatment application to the HFEA when regulatory policies have been determined.”

Declared interests

Prof. Doug Turnbull receives funding from the Wellcome Trust and Muscular Dystrophy Campaign for research into mitochondrial donation techniques.

Mr 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.

Mr 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.”

Prof. Robert Lightowlers: I am a member of the Wellcome Trust Centre for Mitochondrial Research and so we are sponsored by them to perform research in this area.

Prof. Alison Murdoch: I work at NFcL that will be applying to the HFEA for a treatment licence to carry out these procedures in due course.

No other conflicts declared.