Earlier this year, following a consultation on draft regulations, the Government announced that they would be laying regulations before Parliament to allow for the introduction of new techniques to prevent the transmission of serious mitochondrial disease.
Parliament will have an opportunity to scrutinise the draft Regulations and will be asked for its approval before they come into force.
Mitochondria and mitochondrial disease
Mitochondria are found in the fluid surrounding the nucleus of our cells. They are responsible for making energy within the cell, without which the cells would not survive. The mitochondria have their own mitochondrial DNA (mtDNA).
Mitochondrial diseases can affect numerous organs in the body and result in a spectrum of severity of symptoms, which can be life threatening. There are currently no effective treatments for these conditions. It is thought that 1 in 6,500 children will be born with one of the more serious mitochondrial disorders. Mitochondrial disease can be caused by a mutation in either the nuclear or mtDNA. Our mtDNA is inherited only from our mothers, when a woman has an mtDNA mutation, it is inevitable that this will be inherited by her offspring.
Mitochondrial donation could provide an option for women with mtDNA mutations to enable them to give birth to unaffected children. These techniques involve using donor mitochondria for an in vitro fertilisation (IVF) treatment.
The Government has announced that the Regulations to allow the introduction of mitochondrial donation will be laid before Parliament and will be subject to the affirmative procedure and full public and Parliamentary scrutiny.
Prior to this decision by the Government, the mitochondrial donation techniques of maternal spindle transfer and pronuclear transfer were subject to two scientific reviews by the Human Fertilisation and Embryology Authority (HFEA) expert panel (2011 and 2013) with an update in 2014.
The Nuffield Council on Bioethics conducted an ethical review of techniques in 2012 and the HFEA carried out a public consultation which reported its findings in 2013. Following this, the HFEA advised the Government that there is general support for the introduction of these treatments. It has recommended that further research is still needed and the treatment should be offered within a strict regulatory framework.
There are a number of safety and ethical considerations that have been raised in regard to mitochondrial donation. The treatments involve changing the embryo’s mitochondrial DNA prior to implantation. However, the nuclear DNA, which makes up around 99.9% of our total DNA will not be altered by these treatments. There has been some opposition to the proposed introduction of new techniques, and the media have reported that they will lead to three parent babies. If the Regulations are approved, the UK would be the first country to allow for the possible use of mitochondrial donation.
There have been two House of Commons debates on this topic in 2014, the first debate took place in Westminster Hall in March. The most recent was a Backbench Business debate on 1 September 2014, where the motion expressed concerns that more research was needed to ensure the safety of the new techniques, and that the Government should delay the introduction of the Regulations. Members expressed views both supporting and opposing the motion. Fiona Bruce MP introduced the motion and said that to allow the procedures at present would be “tantamount to experimentation.” Members that spoke in favour of the motion expressed ethical and scientific concerns about the introduction of the techniques. Members against the motion highlighted the role of the HFEA in scrutinising the science and said that the techniques were about sparing people from devastating medical problems- not about designer babies or eugenics. The motion was agreed to without division.
The House of Commons Science and Technology Select Committee will hold a one-off evidence session next week (22 October) to consider the science of mitochondrial donation. Andrew Miller MP, Chair of the Committee emphasised the importance of Parliamentary scrutiny of the new techniques:
It is right that the safety and efficacy of mitochondrial replacement techniques are subject to scrutiny in the House. As the Science and Technology Committee, we consider it important that we take the opportunity to scrutinise further the scientific evidence on mitochondrial donation
This Thursday (16 October) the Parliamentary Office of Science and Technology (POST) will hold a seminar on Preventing mitochondrial disease- debate about mitochondrial replacement. The seminar aims to inform the debate on the proposed regulations by giving parliamentarians access to the scientists developing the new techniques and the regulator.
Author: Sarah Barber