Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Baroness Hollins Excerpts

Tuesday 24th February 2015 Lords Chamber

[Baroness Hollins (CB)]

My Lords, I take a rather different view from some of my eminent medical colleagues. I have worked for over 30 years with families of severely disabled children. As a psychiatrist—and as the mother myself of a child born with a severe developmental disability—my heart goes out to those parents facing the prospect of inherited mitochondrial disorders. As a mother, I understand what is called the moral imperative to try to help. However, our first responsibility must be to the children who may be created through these proposed interventions: the most important moral imperative must be to do no harm.

A new technology of such potential importance must take as long as is needed to be as sure as possible of its safety. Being first is not always best. I have carefully read the HFEA 2014 review of scientific methods. It has been implied that the scientific reviews have not raised any concerns, but in paragraph 3.7.25 the review states,

“although the results with the two techniques continue to be promising, further experiments need to be carried out before introducing either into clinical practice to provide further reassurance about efficiency and safety”.

I asked a Written Question in December asking whether clinical trials were being planned and I am grateful for the helpful reply from the Minister and the mention he made of it in his opening remarks—although I disagree with his interpretation of medicine, which is defined much more broadly in the European directive. The Minister also explained that,

“for any new IVF technique there will need to be careful monitoring of the procedure and, subsequently, any pregnancies”.

But we are not talking about pregnancies primarily; this is me as the psychiatrist talking now. As the noble Lord, Lord Deben, pointed out, we are talking about children—children who will, we hope, grow up to be healthy human beings, and who will themselves be able to have healthy children. But what if they do not?

In paragraph 3.7.29 the HFEA expert panel said:

“Until knowledge has built up that suggests otherwise, the panel recommends that any female born following MST or PNT”—

maternal spindle transfer or pronuclear transfer—

“should be advised, when old enough, that she may herself be at risk of having a child with a significant level of mutant mtDNA, putting her child, and if female, subsequent generations at risk of mitochondrial disease”.

The science is complicated, but there is apparently a real possibility that resulting embryos from a woman born after MST or PNT could be heteroplasmic—

[Lord Patel]

May I ask the noble Baroness what experiments she would propose to determine that the children born through this procedure will be healthy in every way, including reproduction-wise?

--- Later in debate ---

[Baroness Hollins]

My Lords, I do not think that intervention is very helpful as it is not relevant to the point I am making. The issue of heteroplasmy was spoken about earlier, and it simply means two or more different mitochondrial DNA types coexisting in a single cell. The review panel concluded:

“These levels may still not be sufficient to cause her children to have a problem, but subsequent generations could be affected”.

In paragraph 4.3 the panel stresses that,

“it should be accepted that there will always be some risk and unknowns associated with the use of MST or PMT in humans until it is tried in practice”.

I understand that and agree with it.

One argument for agreeing the recommendations now is to enable the HFEA to license these techniques as soon as it is convinced that there is sufficient evidence of safety without then having to seek parliamentary approval, thus possibly delaying implementation. In 2008, Dr Evan Harris, the former Member for Oxford West and Abingdon, a champion of the 2008 Act, said:

“Safety is clearly a concern… If Parliament decides that it is not safe enough to allow the HFEA to consider licensing something, Parliament would not draft, confirm or pass the regulations”.—[Official Report, Commons, Human Fertilisation and Embryology Bill Committee, 3/6/08; col. 35.]

Agreeing the recommendations now seems to be putting the chicken before the egg. Supporters of the techniques—

[Viscount Ridley]

The noble Baroness made the point that heteroplasmy, and therefore the carryover of the diseased mitochondria, is possible under this technique. Does she agree that experiments show that the likelihood is less than 5%, whereas pre-implantation genetic diagnosis has it at up to 40%? That is a legal procedure, so we are talking about trying to legalise a safer procedure than something that is currently legal.

[Baroness Hollins]

Again, I do not think that is the point that I am trying to make. Maybe I am not being quite clear enough.

[Lord Tebbit (Con)]

Would the noble Baroness not agree that there is only one absolutely safe way to ensure that this disease is not handed down from generation to generation, and that is for those women who are carriers of the genetic fault not to have children? That may be an appalling thing for me to have said, many people would think, but there are many people who for various reasons cannot have children.

[Baroness Hollins]

That is a good point.

Supporters of the techniques simplify the impact of these proposed procedures by saying that mitochondrial donation is like changing a battery. Their argument runs that mitochondrial DNA relates only to power production in the cell but does not affect the DNA, which encodes our characteristics, and therefore that exchanging mitochondria should not be seen as ethically significant. In a debate last September, the honourable Member for Havant in another place summed up this position well when he said that the techniques represented,

“a change in the membrane of the cell so that the battery function continues, but it does not affect human identity even by 0.1%. That is why I do not believe that there is an issue of dignity or integrity of the individual”.—[Official Report, Commons, 1/7/14; col. 98.]

The Government underlined how important this point was to their policy in their consultation response when they said:

“Most importantly, mitochondrial donation techniques do not alter personal characteristics and traits”,

of the person, the implication being that if this technology were to affect personal characteristics then the Government would withdraw their support.

So the ethics and the safety of the science are inextricably linked. Unfortunately, it seems that we are still at the beginning of understanding the complex interactions between mitochondrial and nuclear DNA. Some recent empirical studies on animals have suggested that mitochondria indeed affect characteristics, and that there is a relationship between mitochondria and memory, temperament and behaviour. As a psychiatrist, I see temperament as a personal characteristic, and I think it was for that reason that the New Scientist withdrew its support for the techniques. In an editorial last year it said that,

“we may have seriously underestimated the influence that mitochondria have. Recent research suggests that they play a key role in some of the most important features of human life”.

I note that the Government’s own consultation document acknowledged the diversity of problems associated with mitochondrial disease, including learning disabilities, neurological problems, autonomic dysfunction and dementia, and that every person’s symptoms are different. The Government’s response to the consultation concluded that they do not alter personal characteristics. One problem that I have with the current proposals is the idea that mitochondria are mere batteries, which is what has been quoted in so many of the papers that have been circulated to Peers. The New Scientist leader comment in September last year said that most debate around the issue had worked on the assumption that mitochondria were simply cellular powerhouses. However, given their newfound influence over our bodies, the implications of this technology may be far more radical than we have assumed. The leader made the point that it seems that mitochondria, far from being passive power plants, influence some of the most important aspects of human life, from memory and ageing to combating stress and disease. They even have influence over the DNA in your cell nuclei and change and evolve during your lifetime.

I have been inundated by emails, as I am sure we all have, from people who are concerned. I had an email from a cell biologist working in California, Professor Paul Knoepfler, who contributed to the HFEA’s call for evidence. He said that,

“mitochondrial transfer might be proven safe, but then again it might not. From my perspective as an impartial (scientific) observer … putting myself at some risk by publicly opposing this technology … its approval at this time would be a … risky gamble with children’s health and lives”.

He says that many scientists have told him that privately they share his concern.

I have one question for the Minister: would he withdraw his support for the regulations if he thought that the role of mitochondria was more than mere power production? Would he then support the amendment of the noble Lord, Lord Deben, for further consideration of this matter?

Until recently, the Wellcome Trust had on its website a statement suggesting that the procedure would be able to go ahead in late 2014, when the science was ready. But is the science ready? I am not quite convinced yet. As noble Lords may be aware, I chair the BMA board of science, which has not yet discussed this matter. I have discussed my support for the noble Lord’s amendments with senior officers of the BMA, and perhaps I may clarify the BMA’s position. Its support for the principle of such reproductive technologies has been expressed as an ethical principle to allow the cautious exploration and development of such technologies. I have concerns about the timing of these regulations, and for that reason I welcome the opportunity to debate them presented by the noble Lord, Lord Deben.

[Lord Ribeiro (Con)]

My Lords, we have heard from legal and medical experts. I am happy to say that I am not an academic and I know very little about the subject. However, it strikes me that if we look at the practicalities from the point of view of the parents who are afflicted by this condition, and we turn back to 1978 when baby Louise Brown was born as a result of the in vitro fertilisation undertaken by Steptoe and Edwards—