Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Debate between Lord Alton of Liverpool and Lord Willis of Knaresborough

Tuesday 24th February 2015 Lords Chamber

[Lord Alton of Liverpool]

I am glad to hear what the noble Baroness, Lady Farrington, has said to us today. It is important that it should be on the Floor of this House, therefore we are all agreed. I contrast the 90 minutes given to the House of Commons to discuss this with the 90 hours that Parliament spent discussing fox hunting. I ask noble Lords to contrast those things. We are required to show due diligence and scrutiny, especially over controversial legislation.

It is not just the absence of the preclinical tests recommended by the HFEA that suggests that the cart has been placed before the horse, but the disingenuous decision by the clinic promoting these regulations—even before your Lordships have debated, let alone approved, these regulations—to offer women money, as we heard from my noble friend Lady O’Loan earlier on, to sell their eggs for these procedures, a practice which itself can be injurious to their health, while telling us:

“It was never about politicians voting on whether it was safe or not”.

That seems almost a contempt of Parliament, and is certainly an extraordinary dismissal of health and safety considerations, which everyone has admitted this afternoon are a consequence of what we are being asked to agree. We have a duty to satisfy ourselves about questions of public safety.

I have experienced this afternoon something of a sense of déjà vu on the arguments, which are so reminiscent of those which persuaded your Lordships to vote for animal/human hybrid embryos in 2007. Although my noble friend Lord Patel, who I think is about to intervene on me again, said earlier on that there was a significant breakthrough by Professor Shinya Yamanaka just two weeks after the Bill passed, that is not entirely accurate. The Yamanaka breakthrough came in 2006 in the journal Cell, not after the Bill passed but before it was even published. If you look back at the Hansard, as I hope Members will, I argued repeatedly that the proposal was redundant because of the Yamanaka breakthrough and that we should not have voted for it. However, despite the Yamanaka breakthrough, many argued that animal/human hybrid embryos were necessary.

Before we rush pell-mell into authorising something which the rest of the world—from the federal agency in the United States to the People’s Republic of China—has prohibited, may I ask the Minister to answer some pertinent questions? First, what regard has he had to the increasing demand for women to give up their eggs for these techniques, the failure of the HFEA to monitor the drugs and dosages used for ovarian stimulation, and published data by Newcastle indicating an incidence of hospitalisation due to such stimulation due to the frequent collection of more than 20 eggs per cycle? Does he regard it as ethical to ask women to sell their eggs for £500?

Secondly, what is the cost of these regulations, both human and financial, when pronuclear transfer—the second of the procedures that have been referred to— requires the destruction of at least two and in some cases 10 healthy embryos for every procedure? Contrast the financial cost, too, of an issue I have raised regularly on the Floor of your Lordships’ House; namely, the failure to provide vital and much needed public funding into finding a cure for diseases such as mesothelioma, which will take the lives of 60,000 British people in the next 30 years.

Thirdly, and more specifically, why have the Government not waited for the outcome of the HFEA’s recommended preclinical experiments before proceeding? Fourthly, like noble Lords today, Dame Sally Davies, the Chief Medical Officer, said at a meeting that I attended with the noble Earl:

“No one will guarantee that it is safe”.

That being so, and given the absence of safety trials, how much has the National Health Service set aside for compensation if safety fears are realised? One recent payment to the parents of a baby damaged at a hospital reached a staggering £10 million.

Finally, I turn to the specific issue of pronuclear transfer. These regulations have bundled together two different procedures. As I said, pronuclear transfer—PNT—unlike maternal spindle transfer, requires the destruction of human embryos. It is a technique that has been specifically advocated by researchers at Newcastle. To date, most applications of this technique have been in mice. However, the Weatherall report of 2006, sponsored by the Academy of Medical Sciences, the Royal Society, the Wellcome Trust and the Medical Research Council, on page 85 stated the following:

“Humans and non-human primates share many features of reproductive biology that are not present in other mammals … Hence, rodents and other non-human primates have only limited usefulness as models of human reproductive physiology”.

Consistent with this, the report of the HFEA’s expert panel in April 2011 said that before the technique could be considered safe to use clinically, it was critical to undertake,

“PNT in a non-human primate model, with the demonstration that the offspring derived are normal”.

Has this been done? Nearly four years later, the answer is still no—even though most postgraduate researchers would have already completed a doctorate within this timeframe.

Strikingly, a news article for the journal Nature stated on 19 January 2012:

“The Newcastle researchers do not have plans to determine whether primates conceived through pronuclear transfer come to term and are healthy”.

Remarkably, the HFEA’s expert panel then changed its mind about preclinical experimentation in primates being critical for pronuclear transfer, in its ensuing report in 2013. The only explanation provided was exceptionally brief and far from compelling. It said that:

“Current research using PNT in Macaques has yet to be shown to be successful. From unpublished data it appears that Macaque zygotes do not survive the PNT process well”.

The panel now believes that the macaque may not be a sufficiently good model for the human. If macaque embryos do not have a good record of surviving pronuclear transfer, and human eggs are even more sensitive, are not problems with human embryos more likely? Surely this suggests the need for proceeding even more cautiously, not less.

The Joint Committee proposed by the noble Lord, Lord Deben, should reflect on the HFEA expert panel’s minutes of 12 February 2013, in which Dr Dieter Egli, of the New York Stem Cell Foundation, explains that he was,

“sceptical about the clinical application of PNT”,

because a structure known as the centrosome may be left behind, and that,

“the consequences of this need to be investigated”.

The proposed Joint Committee should also consider the minutes of the HFEA teleconference with Dr Shoukhrat Mitalipov on 30 January 2013, which reported:

“Dr Mitalipov expressed the view that development of MST or PNT embryos to blastocyst was not in itself enough to give confidence that the techniques are safe and effective”,

and the recent remarks of Professor Justin St John, a geneticist at Monash University in Australia with considerable expertise on the behaviour of mitochondria in nuclear transfer, who said:

“As well as analysing foetal development in a non-human primate model, it is essential to analyse offspring to determine that no abnormalities appear at least during early life”.

Not only have the researchers at Newcastle refused to perform such preclinical research in non-human primates, I have been unable to find evidence of their own prior experience in obtaining healthy offspring of any species following pronuclear transfer, or even in taking any such embryos past the blastocyst stage.

[Lord Willis of Knaresborough]

Clearly, I am not going to get to speak this evening, so I ask the noble Lord a very simple question. Does he have any faith at all in the HFEA to do what it actually says on this tin? If the regulations are passed today it will then have the job of deciding when it will be safe to go ahead and grant a licence. If he does not have that faith in the HFEA, will he please say that? Because I do.

[Lord Alton of Liverpool]

I serve on my own university’s ethics committee, which looks at the use of animals in experiments. Apparently, one of my roles on that committee is to be, as it were, the animals’ friend and to ask whether the experiment is repetitive, whether it is necessary to do such things and what it is going to lead to. There is no one on the HFEA who is the friend of the human embryo. That is a bizarre situation and one I would like to see rectified. But to take the noble Lord at his word, of course I think the HFEA often does a good job, and I admire many of its members.

I will simply say one other thing to the noble Lord. The HFEA is a regulator, not a legislator. That is our duty here today and that is why we are having this discussion. I am conscious that others wish to intervene and I am grateful for the patience of your Lordships’ House in allowing me to put these points. As we ponder on these serious issues revolving around public safety and questions of definition and legality, they deserve far better consideration and scrutiny than has been provided thus far. Surely we should remember the wise advice that those who legislate in haste repent at leisure. Therefore, the proposal of the noble Lord, Lord Deben, for a Joint Committee of both Houses to examine the safety and legality of these regulations deserves our support.