You may have seen some rather sensationally headlined coverage on the news this morning “IVF technique using three biological parents” “Three parent IVF”. This is referring to an IVF technique to avoid passing on mitochondrial disease. This is a treatment which is being researched but is not currently licensed. Andrew Lansley asked the HFEA to report on the current research in this area and this was published yesterday afternoon.
Today, AMRC is a co-signatory of a joint letter to Andrew Lansley asking him to press ahead with developing the regulations to license this technique as a treatment once the research is ready to go.
Some genetic conditions are passed on by DNA in mitochondria. Mutations in this DNA can stop the mitochondria working properly, leading to people suffering disabling and potentially fatal symptoms including blindness, organ failure, muscular weakness, learning disability and diabetes. Research is ongoing to find methods to avoid these unhealthy mitochondria being passed on when someone carrying them has children. Some of this research involves transferring the nucleus from an embryo with unhealthy mitochondria into an embryo with healthy mitochondria (in effect, a child born after this treatment would have healthy mitochondria from a third donor, the “third parent” of the headlines).
Current legislation allows research into this procedure. When this legislation was revised in 2008 (the Human Fertilisation and Embryology Act 2008) Parliament recognized the potential of this research and put in place regulation-making powers so at a future date, regulations could be made to license this research for clinical practice, i.e. to treat people.
Work has been continuing in this area since this was debated in 2008 and the research is now nearing a stage where treatments could be developed.
Earlier this year, the Secretary of State for Health, Andrew Lansley, asked the HFEA’s Scientific and Clinical Advances Committee to review the current research in this area, informing him on the safety and effectiveness of these methods. They looked at the safety and efficacy of the science only.
What has happened now?
The HFEA has published their report and sent it to Andrew Lansley.
The report concludes that there is no evidence to suggest that the techniques are unsafe but calls for additional experiments to be undertaken to further demonstrate the safety of these techniques.
The panel concludes that the techniques of maternal spindle transfer and pronuclear transfer are potentially useful for a specific and defined group of patients whose offspring may have severe or lethal genetic disease, and who have no other option of having their own genetic child. As in every area of medicine, moving from research into clinical practice always involves a degree of uncertainty. The evidence currently available does not suggest that the techniques are unsafe. Nevertheless, these techniques are relatively novel, especially applied to human embryos, and with relatively few data to provide robust evidence on safety. The panel therefore urges that additional research be undertaken to provide further safety information and knowledge about the biology of human mitochondria. The panel proposes a (minimum) set of experiments that it feels is critical. Although optimistic about the potential of these techniques, the panel recommends a cautious approach and advises that this research is carried out, and the results taken into account, before the techniques can be considered safe and effective for clinical use.
We are now waiting to hear from the government how they plan to act on this report; whether they plan to begin the process of developing regulations to allow treatments using this technique to be licensed.
We are concerned that, if these additional experiments are successful, translation of this research into treatments to help those at risk of passing on mitochondrial disease to have healthy children is not unduly delayed by the process of developing regulations in Parliament. It is difficult to justify funding this additional research required to prove this technique without the assurance that successful outcomes can be quickly introduced into the clinic. So today we have written to Andrew Lansley to ask him to publish a timetable for the publication and parliamentary passage of regulations.
This is a joint letter sent by:
- Professor Sir John Bell FRS HonFREng PMedSci President Academy of Medical Sciences
- Lord Willis of Knaresborough Chairman Association of Medical Research Charities
- Alastair Kent OBE Chief Executive Genetic Alliance UK
- Sir John Savill FRSE FMedSci Chief Executive Medical Research Council
- Robert Meadowcraft Chief Executive Muscular Dystrophy Campaign
- Sarah Norcross Director Progress Educational Trust
- Sir Mark Walport FMedSci Director Wellcome Trust
AMRC’s Chair Phil Willis has commented:
Given the current confusion over the future of the HFEA and the setting up of the new Health Research Agency, it is important that the government presses ahead with developing the regulatory framework to enable UK medical science to maximise its progress in this area and ensure UK patients can benefit from research conducted here.
We are now waiting for Andrew Lansley’s response to this letter. We will continue to monitor and voice our concerns in this area.
UPDATE - there's lots of interesting coverage including a nice piece in the Guardian Scientists seek to implant embryos with genetic material from three parents which has tackles the issue of why the tag "three parent IVF" might not be very accurate..
This is not, however, "three-parent IVF", said Professor Robin Lovell-Badge, one of the authors of the review which has now gone to the government. "It is not a term we have used once in this report and it is not a term that should be used," he said. "This is a tiny, tiny bit of DNA. It is not carrying any characteristics except that you have normally functioning mitochondria."
And Evan Harris's Political Science blog has a nice piece with background on the current legislation and what government needs to do next.