Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Baroness O'Loan Excerpts

Tuesday 24th February 2015 Lords Chamber

Finally, is it rushed? Far from being hurried, it has been under development for more than 30 years, under debate for 15 and under scrutiny for five. There is nothing slippery about this slope. There has been no rush. Now, however, that we have reached this stage there jolly well should be some reasonable haste on behalf of the women whose reproductive life is running out and who desperately want their own child, people such as Claire Wright, who is now 40 and who had to watch her son Jacob lose his smile on the way to a cruel death. Yes, there is understandable urgency. We would have to have very good reasons to argue that the ethical thing to do is to prolong her suffering and that of others like her. I cannot see those reasons.

[Baroness O'Loan (CB)]

My Lords, I very much support the Motion that has been tabled by the noble Lord, Lord Deben, for the reasons he very articulately expressed. The Minister has reassured us significantly about these regulations, but he did express many of the uncertainties that remain. In moving his Motion, the noble Lord, Lord Deben, talked about uncertainty. The noble Lord, Lord Patel, gave us graphic details of the uncertainties of the two processes that are proposed, which may result in increased risk of chromosomal defects. In the light of all that uncertainty, how can it be right that your Lordships’ House be asked to make a decision of this magnitude before the conclusion of all the necessary research?

I want to talk briefly about one issue that relates to the protection of women’s health. We are told that these proposals are all about advancing women’s rights, and yet it seems to me that we are at risk of overlooking one very important matter in relation to which these procedures plainly do not advance women’s rights. That is the repercussions of the increased demand for donor eggs for the women who donate the eggs. The requirement for more eggs is a consequence of scientific development, and that is widely accepted. A Nuffield Council on Bioethics report looked into the ethical issues around mitochondrial donation and stated:

“One of the major barriers mentioned by scientists when assessing the potential for cell reconstruction techniques to become treatments is the fact that many more egg donors will need to be found to undertake the research required in order for the safety and efficacy of PNT and MST to be established, and if therapies are to be provided in future. A shortage of egg donors is an acknowledged problem in respect of donations for reproduction, and it is not yet clear whether egg donors would be more likely to come forward”.

[Lord Winston]

I am grateful to the noble Baroness for giving way, but I do not think that she speaks from experience. Sadly, I have to say that I do speak from experience. I have run a very large infertility practice for a very long time, and we found donors very easily when it was concerned with these sorts of serious conditions. There was never a problem about finding donor eggs for this kind of problem.

--- Later in debate ---

[Baroness O'Loan]

I thank the noble Lord for that intervention. However, the research shows that there is a shortage of women donors.

Eggs used have to be extracted from women’s ovaries by a process known as controlled ovarian hyperstimulation, which can lead to complications for women. According to the Royal College of Obstetricians and Gynaecologists, it affects up to one in three women to some degree. It says that between 3% and 8% of IVF cycles are complicated by either moderate or severe OHSS, which can cause a variety of painful and upsetting symptoms such as abdominal pain, nausea, diarrhoea, haemoconcentration, thrombosis, pleural effusion and respiratory distress. It can be further complicated by ovarian rupture and renal insufficiency. In some cases, it can be life-threatening.

The Newcastle Centre for Life conducted research on the prevalence of OHSS and published the results. It found that the risk of hospitalisation increased massively if more than 20 eggs were collected. We do not know whether the pattern that it established is repeated at other research centres because the data have not been compiled. There is a gap in the evidence base. The really important point is that, as I understand it, the collection of 20 or more eggs is very common in the UK. Tens of thousands of women have been through the process, so there is a substantially increased risk of a serious medical condition.

Mitochondrial donation is impossible without a supply of donor eggs. The procedures rely on the willingness of women to undergo a process which may bear serious health risks and about whose safety there are not extensive data. Two Answers were given in Parliament last summer which suggested that the monitoring of the incidence of ovarian hyperstimulation syndrome is inadequate. On 9 July, the Health Minister in another place said:

“The HFEA does not, therefore, hold definitive data on the number of women admitted to hospital with OHSS, including non-patient egg donors and egg-share donors”.—[Official Report, Commons, 9/7/14; col. 313W.]

On another occasion, it was said that,

“licensed fertility clinics are only required to report instances of OHSS to the authority that require a hospital admission with a severe grading”.—[Official Report, Commons, 24/6/14; col. 157W.]

It was stated that other cases were reported as well. I do not think that the Government have given enough consideration to the effects of the legalisation of mitochondrial donation on the donor’s health. There is a possibility that it will lead to further problems.

This concern is underlined very effectively by the fact that the Newcastle scientists pressed Parliament very hard to sanction legislation to permit the creation of animal hybrid embryos. Parliamentarians who recall that debate will remember that the principal justification for changing the law was to allow the creation of admixed human embryos in order for research to be conducted without it being dependent on human eggs because of their limited availability. The legislation was passed; the research is dead.

[Lord Patel]

I thank the noble Baroness for giving way. It is important to clarify that point, particularly as it was crucial in the debate on that amendment. Admixed embryos were required for the research to be carried out then in order to study the diseases in embryonic stem cell lines without using human eggs. She is correct in saying that. On why that research has been abandoned, as the noble Lord, Lord Alton, may well remember, I made the comment in closing that the utopian dream of the scientist would be that, one day, we might reach a point where we were able to take a skin fibroblast and down-regulate it so that it behaved like a pluripotent cell. That dream came true two weeks after that legislation was passed, when Yamanaka in Japan published an article saying how it could be done. That is why the research stopped; it was not because it could not be done.

[Baroness O'Loan]

I thank the noble Lord for his intervention. It remains the case that there is a shortage of donated eggs. My concern is for the women who are asked to donate eggs.

[Lord Alton of Liverpool (CB)]

I am sorry to interrupt my noble friend, but, given that my noble friend Lord Patel mentioned this case, perhaps I might reinforce what she is saying, because Newcastle is not offering to provide donation opportunities for women but is asking them whether they will sell their eggs, at £500 per cycle. We all know that that can lead to hyperovulation syndrome, an issue which I raised in your Lordships’ House last week and which I know concerns many of us from all sides of this argument. So there is another dimension involved in this. My noble friend Lord Patel was also right to say to my noble friend Lady O’Loan that when we debated these issues in 2009 many of us pointed to things like adult stem cells and the work being done by Professor Shinya Yamanaka. We said then that arguing for animal/human hybrids was a diversion when much more important work, like that which the noble Lord, Lord Patel, has just mentioned, could have been undertaken.

[Baroness O'Loan]

I thank the noble Lord for that intervention. I am not arguing against this process; I am arguing against the introduction of these regulations at this time in the absence of sufficient knowledge and protection. We have to look at the factors, as the noble Lord, Lord Alton, said. Being paid to donate one’s eggs constitutes a very serious issue for women who are in poverty and who will do it as a way of raising money, possibly even to look after their own children. We need to provide protection for such women.

In conclusion, we should not hasten ahead without putting in place clear and comprehensive systems for monitoring the outcomes of all controlled ovarian hyperstimulation treatments, including those treatments that would result in the generation of eggs to facilitate PNT and MST. In this context, I simply ask that we proceed more carefully and that we back the Motion moved today by the noble Lord, Lord Deben.

[Lord Winston]

My Lords, I declare an interest in that it was my scientific group which started pre-implantation diagnosis—the first attempts to diagnose genetic diseases in embryos in families who have these fatal, sad genetic flaws in them. I congratulate the Minister on his absolutely balanced and fair speech. From time to time, we have not agreed, but I think that his care, compassion and courtesy are deeply appreciated by the whole House. I also congratulate the noble Lord, Lord Deben, on his very clever speech. I do not agree with what he said and I hope that, at other times, we can see why we disagree. I accept that he is talking with deep conviction, but I think that we have already sorted out most of his objections, both the legal and the difficulties of side-effects.