UK Opens Public Consultation on Draft Regulations to Permit “Three-Person Embryos”

Posted by Jessica Cussins March 6, 2014
Biopolitical Times
picture of microscope

The UK Department of Health has released draft regulations and begun a three-month public consultation for what it terms “mitochondrial donation.” After the consultation concludes, final regulations will be written and then put before Parliament for a vote. According to media reports, it is possible that licensed fertility clinics in the UK could offer the techniques before the end of this year.

These controversial oocyte and embryo manipulation techniques, which would result in trans-generational changes to the human genome, have also been widely covered in the US media recently. Last week’s FDA public meeting to discuss them coincidentally took place two days prior to the UK’s announcement, which had been expected for months.

Certainly, each country is watching the other. Perhaps neither is quite sure it wants to be the first to violate the widespread international agreement against modifying the human germline, and incur the controversies that will inevitably ensue. But there also are those in both countries who are eager to stay at the forefront of a new biomedical field.

If the FDA pays any attention to what came out of its advisory committee meeting, it will require much more substantial research to be carried out prior to human clinical trials. For now, the UK is further along in its policy process. Unless members of Parliament are made aware of the many social and safety concerns raised by these techniques, a “rubber stamp” vote could be in the works. Based on the 47-page document the Department of Health has released, there are many reasons for concern.


What should we call it? One of the document’s misrepresentations is its title. “Mitochondrial Donation” is the most euphemistic terminology for these techniques I’ve seen. As the document acknowledges, it’s not mitochondria that are being moved around; the techniques actually involve “the transfer of nuclear material between eggs and embryos.” And, of course the term “donation” is a well known euphemism for what really occurs in the market for women’s eggs.

How many people are affected? The “Executive summary” gets off to a bad start. The second and third sentences say,

“It is estimated that 1 in 200 children are born every year in the United Kingdom with some kind of mitochondrial DNA disorder. Serious mitochondrial disease can have a devastating effect on families including the premature death of children, painful debilitating and disabling suffering, long-term ill-health and low quality of life.”  

This framing will certainly encourage readers’ sympathy for anything that can lessen this level of devastation. But it is extremely misleading. While it is true that about 1 in 200 people have some kind of mitochondrial mutation, the vast majority are completely healthy. Most accounts clearly acknowledge this. But you have to make it to page 41 of the Department of Health’s document to come across the explanation that

“Mitochondrial disease currently affects around 12,000 people in the UK, with one in every 6,500 babies born with a form of the disease. The technique being legalized here will apply to the most severe cases in the first instance. An estimate provided by the Wellcome Trust Centre for Mitochondrial Research at the University of Newcastle suggests mitochondria donation treatment could apply to up to 10 cases per year initially.”

That paints quite a different picture.

GM humans? The document’s sole mention of the highly problematic fact that, if approved, these techniques will result in genetically modified babies, is in one paragraph that states that they would “only substitute, rather than alter” DNA. Though this is an important distinction to make in writing regulations, the child’s DNA will be altered. In fact, the paragraph concludes that “it would though be a form of germ line modification.”

Is there really public support? In its discussion of last year’s public consultation conducted by the Human Fertilization and Embryology Authority (HFEA), the document does note that the majority of people who responded to the open questionnaire (which – with over 1,800 responses – had by far the largest numbers) were opposed to the technique. But it downplays the importance of this fact, saying that these views were from “a self-selected sample,” as if that should discredit them. On the contrary, the fact that this was the only section of the public consultation in which participants were not hand-selected by those in charge of the process says a lot.

What will it cost? A truly fascinating part of the document is the section that projects what these procedures would actually cost for the women who are interested in them. The estimated cost of a successful “mitochondria donation treatment” is £80,000 (about $133,000). This cost accounts for two rounds of standard IVF to extract eggs from two women, one round of PGD to test for the presence of mitochondrial disease in the extracted embryos, and an assumption that it will take four cycles to generate a successful conception.

This price tag puts the proposed treatment out of reach for most people. Further, the document notes that “it is possible that this is an under-estimate of the actual cost.” That does seem likely, since there are important differences from traditional IVF that would likely drive up the costs. Finding egg donors would be more time consuming and expensive because each would have to undergo additional examination to make sure they have no mitochondrial mutations of their own; only a handful of embryologists have the skills to carry out this procedure; and it seems highly unlikely that success rates using these techniques would mirror those of traditional IVF.


As the Department of Health document explains, when the UK in 2009 decided that the country’s law prohibiting human germline modification could be amended to allow mitochondrial manipulation techniques down the road,
“the Government of the day gave an assurance that such regulations would not be made until any proposed techniques were considered to be effective and safe for use in treatment.”

As Dr. David King, director of Human Genetics Alert, recently pointed out,

“The techniques have not passed the necessary safety tests so it is unnecessary and premature to rush ahead with legalization.”

I agree. Nonetheless, here are some comments on the draft regulations as they currently stand.

Less risky alternatives. The Department of Health’s draft regulations set two preconditions for eggs and embryos that can be used in this procedure: they must have a particular risk of mitochondrial abnormality, and there must be significant risk that a person with this abnormality will develop a serious disability or illness. I think a further condition ought to be set: that there are no safer alternatives available. Given the UK clinics that already offer embryo screening (pre-implantation genetic diagnosis, or PGD) for the prevention of the transmission of mitochondrial disease, and the growing evidence of its efficacy in most cases, candidates for oocyte or embryo modification should consider it first.

Mandating no disclosure to children. The draft regulations state that at the age of 16, a person who thinks they were born following this technique could ask the HFEA for confirmation and view information on their donor’s medical history, but would not be given access to the donor’s identity. The regulations also say that women who provide their egg cytoplasm and mitochondria are determined to be “not related to any children who were, or might have been, born following treatment services using their donation,” so

“therefore no provision is made to allow access to information in connection with entering into a marriage, civil partnership or intimate physical relationship, nor to access information about other children who share the same donor.”

This seems short-sighted. Even though the HFEA thinks that mitochondrial donors should be treated more like organ donors than gamete donors, we don’t know whether any kids that are born will feel the same way.


Though the chances might be low, I do think it’s possible that the UK will decide not to move forward with these experimental techniques. The document notes that

“The Government has decided to proceed with regulations. However, before taking the decision to submit regulations for the scrutiny and approval of Parliament, we will ask the HFEA to reconvene the Expert Panel a further time to provide an updated assessment of the safety and efficacy of these techniques.”

It adds that “When the amendment was made no commitment was given on a timescale for making regulations,” and in response to opposition at that time, it was determined that they would only be used “once the techniques involved were considered to be effective and safe for use in treatment.”

Could this be a hint that some of those involved want a potential out? The safety and efficacy of mitochondrial manipulations were just considered in detail at the FDA meeting, and a long litany of problems emerged. Hopefully, the UK Department of Health and the members of Parliament will take note. For that reason, taking part in this public consultation may turn out to be very important.

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