PEOPLE who have concerns about mitochondrial replacement can be confident in the UK's regulatory system, the Bishop of Swindon, Dr Lee Rayfield, said on Wednesday. He was speaking after MPs voted in favour of draft regulations permitting the new IVF techniques to take place.
"I believe that the system for regulation in the UK is robust, and there will be a virtuous circle in making sure that nobody puts in an application for a licence which would result in the technique losing public confidence," he said.
Last week, a statement from the C of E's national adviser on medical ethics, the Revd Dr Brendan McCarthy, recommended that the law should not be changed, "until there has been further scientific study and informed debate into the ethics, safety and efficacy of mitochondrial replacement therapy".
On Tuesday morning, Dr Rayfield sought to correct the impression that the Church was trying to "put the brakes on progress".
"There are still questions around safety and efficacy," he wrote in The Sun. "The Church of England wants to ensure that these are answered as well as possible before the technique is permitted. . . Our desire in the national Church is for mitochondrial replacement to bless many and provide an answer to their deepest hopes and prayers for generations to come."
During an appearance on Today on Radio 4, on Tuesday, he expressed regret about the Church's communication of its position.
"I'm not going to come out against this, because I think this hasn't been our finest hour for the Church of England, at least, in getting our message across," he said. "We seem to have been heard as stressing some of the caution so much, that we've only been heard as anti." The Church's position was "nuanced", he argued. Some members, "like myself, are more confident than others".
On Wednesday, he set out the concerns within the Church in more detail, providing in full the statement edited for length by The Sun.
This states: "One particular concern - especially as mitochondria contain their own distinct DNA which goes down the generations through the mother's line - is unknown interactions between the genes in these organelles and those in the nucleus.
"Although safety and efficacy are being closely monitored by an Expert Group, and it is recognised that there will always be a risk in applying a novel technology such as this, there is wariness about changing the law until greater assurance can be provided.
"The science is new, and public confidence can be fragile and easily disturbed; there are many voices in the Church urging caution - not to put the brake on progress but to ensure we get this treatment on as sure a foundation as possible."
Dr Rayfield was a member of the Human Fertilisation and Embryology Authority (HFEA) group overseeing the public consultation on the technique. The HFEA says that there is "general support" from the public for permitting the technique (News, 2 January). An expert scientific panel, convened to review the safety of the technique, concluded that there was no evidence to show that it was unsafe.
The health minister Jane Ellison said during the MPs' debate on Tuesday that "all reasonable and rigorous steps have been followed to reach this point. This is a bold step for Parliament to take but it is considered an informed step."
The shadow health minister Luciana Berger suggested that it was "possible that side-effects could emerge over time, and scientists have acknowledged that there would always have to be a 'leap of faith' the first time the technique is used in humans".
In September, an editorial in the New Scientist highlighted new research that suggested that "we may have seriously underestimated the influence that mitochondria have. Recent research suggests that they play a significant part in some of the most important features of human life. This raises the ethically troubling prospect - once widely dismissed, including by this publication, that children conceived in this way will inherit vital traits from three parents."
A sticking-point of the House of Commons debate was whether the technique could be defined as genetic modification. The Government's position is that it is not, but Ms Ellison acknowledged that "there is no international or universally accepted definition." MPs drew attention to the HFEA's own consultation document as having said that one of the techniques "involves genetically modifying a human embryo".
Germ-line modifications have never been permitted on embryos. The UN's Universal Declaration on Human Genome and Human Rights describes the human genome as "the heritage of humanity", and gives the International Bioethics Committee a duty to identify "practices that could be contrary to human dignity, such as germ-line interventions".
Fiona Bruce, the Conservative MP for Congleton, warned that approval of the techniques would mean that the "genie is out of the bottle". She urged MPs to draw a "red line", and highlighted several polls suggesting that the public opposes the techniques. MPs voted in favour of the draft regulations by 382 to 128.
Mr Cameron told LBC Radio on Tuesday that the procedure was "not playing God with nature. . . Those arguing for the change point out that this is not an absolutely fundamental issue of designer babies: it's about dealing with a problem."
If approved by Parliament - the House of Lords must now vote - the UK would become the first country in the world to permit the creation of babies with DNA from three people.
The techniques have been developed to enable women who suffer from a form of mitochondrial disease, caused by faults in the DNA of mitochondria (often described as the human cell's batteries), from passing it on to their children.
It is estimated that this could help 150 couples a year. About one child in 200 is born each year with a form of mitochondrial disease. Most cases are mild or asymptomatic. About one in 6500 is estimated to develop a more serious, even fatal, mitochondrial disorder.
Before licences are issued, providers of the technique will have to demonstrate that they can carry out the procedure safely and effectively, and that treatment will be approved case by case.
Besides safety concerns, some opponents of the techniques have expressed concerns about the ethics involved, including questions of identity. Draft regulations state that those who donate mitochondria will remain anonymous.
'Ethics: Yes, No, Don't Know' - press column
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