Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Lord Elton Excerpts

Tuesday 24th February 2015 Lords Chamber

[Earl Howe]

I can only say again that the legal advice I have had is that the charter cuts in only when there is an issue of European law. We do not consider that treatment services, which are what we are talking about here, are covered by EU law. The noble Baroness made a point of saying that my right honourable friend the Attorney-General did not vote in favour of the regulations, but it is difficult for me to comment on that. There was, rightly, a free vote in the other place, just as there is here. I cannot comment on the personal view of the Attorney-General—and I have to say that I do not think that anything said or quoted by the noble and learned Baroness threw much light on that issue.

I repeat that my department is confident that these regulations are necessary and have a sound legislative base in the Human Fertilisation and Embryology Act 1990, as amended. As my noble and learned friend Lord Mackay rightly pointed out, it was the clear intention of Parliament that this provision would enable mitochondrial donation to take place in a clinical setting.

On the issue of safety, my noble friend Lord Deben urges us to delay until further research is carried out. However, we could wait indefinitely for research and follow-up and still not have a 100% assurance about safety, because that is the nature of science and research. The standards of assurance that some are seeking are considerably higher than those for cancer treatment or heart disease. As far as the expert panel convened by the HFEA is concerned, there is no evidence to suggest that these techniques are unsafe. The critical experiments are progressing positively.

As I said, the mitochondrial donation regulations require the HFEA to assess each application for mitochondrial donation on a case-by-case basis. That will include consideration of the evidence on safety and effectiveness. As a statutory independent regulator, it is for the HFEA to determine its own procedures for assessing applications to carry out treatment regulated by the 1990 Act. Applications to provide mitochondrial donation treatment are no exception to this rule but, clearly, the HFEA will not authorise the treatment if it does not consider it safe to do so.

It is never possible to answer every safety question before new medical procedures are used in people for the first time. New techniques can be refined and reviewed. Even the most exhaustive research can establish only that a technique is sufficiently likely to be safe to justify “first in human” treatment. However, if medicine is to progress, clinicians should in my submission be permitted to use new techniques when evidence suggests these are sufficiently safe and effective. It is the Government’s view that medical knowledge in the field of mitochondrial disease and donation has now reached this stage and it is time to progress. The legislative framework of the HFE Act provides for Parliament to endorse the Government’s view before proceeding and, following the extensive process of consideration that I have already set out, we have properly brought this to Parliament for debate on affirmative regulations.

I listened with care to the noble Baroness, Lady Hollins. I absolutely concede that there is a balance of risks to be considered. As I have said, it is not possible to be certain that new medical procedures will be 100% safe or effective. These risks must be balanced with the risk of ongoing suffering for families with mitochondrial disease. For me, the simple point is this: scientific evidence suggests that any risks of mitochondrial donation are proportionately less than the significant risk that children will continue to be born who will develop severe mitochondrial disease if these techniques are not used. As the noble Lord, Lord Patel, pointed out, ultimately it will be up to affected families to judge the balance of these risks with advice from their clinicians and then to decide whether they choose to proceed with treatment, subject to authorisation by the HFEA.

My noble friend Lord Deben mentioned the Chinese study. That study has not been published and we understand that it will not be. It concerns one pregnancy, using an earlier form of pronuclear transfer. One of the clinicians involved gave a full interview to the Independent recently and explained that the complications that occurred related to multiple pregnancies from multiple embryo transfer, rather than from the mitochondrial donation process. As I understand it, there were no genetic abnormalities in the foetuses.

Turning again to the speech by the noble Baroness, Lady Hollins, the HFEA-convened expert panel considered the issues that she raised: if the patient and the donor have different mitochondria, known as haplotypes, the donor’s mitochondria may not, as it were, “talk properly” to the patient’s nuclear DNA, causing health problems. The panel considered that as part of its third scientific review. However, it was of the view that the data submitted to it about this potential problem were not relevant enough to raise safety concerns. However, the panel has recommended, as a purely precautionary step, that consideration be given to the mitochondria haplotype when matching donors to patients, even though the risks of not doing so are assessed to be very low.

The noble Baroness questioned whether successive generations, particularly girls, could have the same problems arise from unhealthy mitochondria. The principle behind the treatment is that the mitochondrial DNA that the child will inherit will be the disease-free mitochondrial DNA of the donor, not the faulty mitochondrial DNA of the mother, although there is a small risk that the low level of unhealthy mitochondria may be carried over when the patient’s nuclear DNA is moved from her egg or embryo to the donor’s. Evidence continues to be reassuring that carryover after mitochondrial replacement is very low and unlikely to be problematic. The risk of mitochondrial disease being present in these generations will, we believe, be low.

The noble Baroness also said that we still do not know enough about the relationship mitochondria have with the human body. This is true of many aspects of human physiology, not just mitochondrial DNA. The majority of the evidence indicates that mitochondria are primarily concerned with generating the power that every cell in the body needs to function. It is generally accepted that, as vital as the function of the mitochondria undoubtedly is to the human body, they do not play a role in developing a person’s physical appearance or personality traits, which are derived solely from nuclear DNA.

[Lord Elton (Con)]

Before my noble friend leaves the question of risk, may I ask him to close a little chink in the reassuring curtain that he is drawing before us? We are assured by the HFEA that there is no evidence of risk in what is proposed, but it also proposes quite a large phalanx of experiments that should be completed before proceeding. First, there appears to be a slight logical discontinuity there. Secondly, can we be reassured that, in the Minister’s view, the HFEA will not proceed to licensing anybody until they have completed that programme of experiments?

[Earl Howe]

My Lords, I can confirm to my noble friend, and to the noble Lord, Lord Hunt, who asked a similar question, that the expert panel stated that the further experiments that it recommended could take place either before or after the passing of these regulations. However, they must be done before treatment can take place. I hope that that is sufficient reassurance.

The noble Lord, Lord Alton, and the noble Baroness, Lady O’Loan, spoke about the risk of ovarian hyperstimulation syndrome. OHSS is a well recognised side-effect of the drugs used to stimulate a patient’s or donor’s ovaries to collect multiple eggs for use in fertility treatments. The risks of OHSS are very well understood, with patients and egg donors carefully monitored. The HFEA’s code of practice requires women undergoing ovarian stimulation to be given information about the possible side effects and risks, including OHSS. Women are informed of the symptoms to look out for and are warned to contact their clinic if they feel unwell. Women donating eggs for use in mitochondrial donation will not be at any increased risk of developing OHSS.

The noble Lord and the noble Baroness both questioned the practice of paying for donated eggs. I submit that there is nothing sinister in that. Within the legal framework of the HFE Act, the HFEA sets the rates for compensation to donors of eggs or sperm; £500 for an egg donor is well within those limits. It certainly is not a sign that Newcastle University is anticipating the introduction of the regulations to allow mitochondrial donation. It is continuing its research and has an ongoing need for donated eggs for that purpose.

I turn now to the issue of definitions. In making the regulations, the Government have been clear about their approach, the definitions used and the source of their material. The Government’s consultation on the detail of the regulations set out very clearly: the definitions of scientific terms; the detail of the techniques that the draft regulations would cover; the terms that others might use, such as “genetic modification”; and the proposed approach to information for donors and those conceived through mitochondrial donation.