The Department of Health is introducing regulations permitting three parent mitrochondrial donations with IVF treatment with the aim of producing babies that have healthy mitrochondria.. This proposed treatment is not universally accepted, because of safety reasons and the ethical consequences on future generations.
These regulations are expected to be debated and voted on by MPs before the general election, and could even be passed within weeks, despite safety concerns. So far no time-table for Parliamentary debate has been agreed or planned but is thought to take place within the next few weeks.
Mitochondrial donation uses genetic material from the eggs of two women, combined with the sperm of a man, to produce IVF embryos that are free from serious mitochondrial diseases, which currently affect about one in every 6,500 children. Proponents argue it will help those women who carry mutations in their mitochondria – the tiny “power packs” of the cells – from passing on inherited conditions to their children, as the 37 genes of the mitochondria are inherited maternally.
The Department of Health claims that the technique is a form of germ-line therapy which will affect future generations but has dismissed suggestions that it also amounts to genetic modification of embryos with “three biological parents”. Opponents argue the technique is unsafe and might lead to a “slippery slope” of designer children.
The US Food and Drug Administration has said it would take at least another two years to carry out the necessary safety studies before the first American clinical trials on mitochondrial donation, but scientists in Britain have said they can carry out the procedure as early as this year if legislation is passed.
Former President of the Catholic Union Lord Brennan QC claims that the new three-parent baby law ‘is flawed and open to challenge’, furthermore he raises doubts over the legality of the proposed regulations. He also states that legislation to allow mitochondrial donation is either unnecessary or invalid under the Human Fertilisation and Embryology Act.
His written opinion, which has been passed to parliamentary authorities, says there are “significant doubts” about the legality of proposed regulations being introduced by the Department of Health.
He also states: “If the regulations are approved in their current form, they may be open to challenge by way of judicial review.”
The Government has introduced new regulations to allow mitochondrial donation because it was thought that the controversial IVF technique was specifically banned under the Human Fertilisation and Embryology Act 2008. The Act defines a “permitted” egg or embryo as one whose “nuclear or mitochondrial DNA has not been altered”, where “altered” is defined as the introduction of any sequence of nuclear or mitochondrial DNA into cells of the embryo.
However, recent ministerial statements have said that mitochondrial donation does not involve altering mitochondrial DNA. These statements have been used to emphasise the Government’s stance that mitochondrial donation will not lead to the genetic modification of human eggs, embryos or babies.
“The proposed mitochondrial donation techniques only allow for unaltered nuclear DNA to be transferred to an egg or embryo that has unaltered healthy mitochondria,” the Government said last year. “The key consideration is that these techniques only replace, rather than alter, a small number of unhealthy genes.”
Lord Brennan argues that the statements undermine the rationale for the new regulations on the grounds that they would be unnecessary if mitochondrial donation does not alter genetic material.
He adds: “The Department of Health’s ministers have now told Parliament on several occasions that they do not consider mitochondrial donation to alter the DNA of either an egg or embryo.
“The problem with this suggestion is that, if it is correct, there would be no need for the regulations at all, because mitochondrial donation would be allowed under the Act itself. Thus either these regulations are ultra vires [invalid] or they are unnecessary.”
The new regulations have already been rubber-stamped by Parliament’s Joint Committee on Statutory Instruments. The Department of Health has promised a debate and vote in both Houses of Parliament.
A Department of Health spokesperson said: “Mitochondrial donation will give women who carry severe mitochondrial disease the opportunity to have children without passing on devastating genetic disorders.
“An independent parliamentary committee has considered the regulations and did not raise any issues for Parliament’s attention. The regulations will be considered further as they go through Parliament.”