Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Earl Howe Excerpts

Tuesday 24th February 2015 Lords Chamber

Moved by

[Earl Howe]

That the draft regulations laid before the House on 17 December 2014 be approved.

Relevant documents: 23rd Report from the Secondary Legislation Scrutiny Committee and 17th Report from the Joint Committee on Statutory Instruments

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, the purpose of the regulations is to enable women to have their own genetic children, free of terrible disease caused by disorders in their mitochondrial DNA. The regulations do so by allowing healthy mitochondria from a donor to replace the unhealthy mitochondria in a woman’s egg or embryo.

Mitochondria are present in almost every cell in the body and produce the energy that we need to function. This is why they are often referred to as the “powerhouse” of the cell. Unhealthy mitochondria can cause severe medical disorders known as mitochondrial disease, for which there is no cure. There are 37 genes in the mitochondrial DNA, compared with more than 20,000 in the nuclear DNA. This represents less than 0.1% of the total genetic make-up. The techniques provided for by these regulations offer the only hope for some women who carry the disease to have healthy, genetically related children who will not suffer from the devastating and often fatal consequences of serious mitochondrial disease.

Provision to make these regulations was introduced by Parliament into the Human Fertilisation and Embryology Act 2008. It followed an amendment that recognised the progress being made in research. In 2010, researchers at Newcastle asked the Department of Health to take forward steps to develop regulations. Over the last five years, there has been extensive engagement and consultation with the public on this issue, including, first, an ethical assessment by the Nuffield Council on Bioethics in 2012; secondly, a highly commended, respected and wide-ranging public dialogue and consultation exercise carried out by the HFEA in 2012-13; and, thirdly, a public consultation on draft regulations carried out by the Department of Health in 2014. There have been three separate reports into the safety and efficacy of these mitochondrial donation techniques by an expert panel convened by the HFEA, published in 2011, 2013 and 2014. The expert panel members were selected for their broad-ranging scientific and clinical expertise, and for having no direct or commercial interest in the outcome of the review.

This process was commended in a recent letter to the Guardian from eminent scientists and Nobel Prize winners from the UK and across the world. The letter included this sentence:

“the UK has run an exemplary and internationally admired process for considering benefits, risks, ethical issues and public consent, which must properly precede a change in the law”.

Given the extensive scrutiny given to this issue during the life of this Parliament, I believe it is appropriate to allow this Parliament to decide whether to take the next step for mitochondrial donation, which can make meaningful progress to actually help families only with the passing of these regulations. The two proposed techniques that would be allowed under these regulations are maternal spindle transfer and pronuclear transfer. These replace the mitochondrial DNA, which contains a small number of unhealthy genes, with healthy mitochondrial DNA. Mitochondrial DNA is just 0.054% of our overall DNA. One important point to emphasise here is that none of the nuclear DNA, which determines our personal characteristics and traits, is altered by mitochondrial donation.

I know that many noble Lords will have their own tributes to pay, but I would like to make my own acknowledgment of the ground-breaking work that the scientists at Newcastle University have led, which is world-leading in the development of these new techniques. It is also very important to praise the Lily Foundation, a charity founded by families who have lost their children to serious mitochondrial disease, which has reminded us about the human story that inspired this scientific advance.

I turn now to the detail of the regulations made under powers in the 1990 Act which, as I said, were added in 2008, with Parliament’s express agreement, in anticipation of the advancement of science to this point. These powers would permit mitochondrial donation in order to prevent the transmission of serious mitochondrial disease.

--- Later in debate ---

[Lord Hunt of Kings Heath (Lab)]

My Lords, I sense that the House wants to come to a decision.

Just over 14 years ago, I asked the House to agree that embryology research could be extended to cover diseases such as Parkinson’s disease, Alzheimer’s disease, cancer and diabetes. This provision had been anticipated and included as a regulation-making power in the Human Fertilisation and Embryology Act 1990, which had allowed embryology research but only for conditions such as infertility and congenital diseases.

The 2001 regulations were passed following a Motion moved by the noble Lord, Lord Alton, to whom I pay tribute for his integrity and perseverance. However, his Motion to establish a Select Committee prior to the regulations being approved was defeated by 212 votes to 92.

The 1990 Act followed the work of a committee led by the noble Baroness, Lady Warnock, which made recommendations on developments in science and medicine in relation to human fertilisation and embryology. I pay tribute to the noble Baroness for her outstanding work in helping us get the balance right between the respect owed to human embryos and the potential for the use of embryos in research and treatment for devastating illnesses.

The 1990 Act was a model in the regulation of certain infertility treatments and embryo research. It reflected the need to have a strict framework in which regulation could be conducted to take account of the advances in medicine anticipated by both the noble Baroness, Lady Warnock, and Parliament in 1990.

Since 1990, the science and research have developed, just as has the need for Parliament to keep up and anticipate further developments. Thus, in 2001, we passed emergency legislation to put it beyond doubt that human reproductive cloning could not take place in the UK. In 2004, we passed regulations in which the identity of the donor of eggs, sperm or embryos could be given to the adult donor-conceived person under certain circumstances.

We have heard about the 2008 Act, which amended the 1990 Act to include restrictions on the types of embryos that may be placed inside a woman. Importantly, the 2008 Act amended the 1990 Act to insert a regulation-making power to enable techniques which were under development at that time to be used in treatment to prevent a child being born with serious mitochondrial disease. Surely, the noble Viscount, Lord Ridley, and the noble Lord, Lord Walton, are right—at every significant stage of embryology research and potential treatment, Parliament has been asked to give its approval and thus ensure public confidence in our scrutiny of these most difficult decisions. My view is that Parliament has discharged that responsibility thoroughly and well. However, I am glad that the noble Lord, Lord Deben, has given us the opportunity to have this debate. Of course, we would have had a debate but the noble Lord has served a great purpose in encapsulating the core argument and I am grateful to him for so doing.

We find ourselves asked to make a crucially important decision, with powerful contributions having been made on both sides of the argument. On the one hand, we celebrate the triumph of science that these new techniques represent. We have within our reach the possibility of eradicating mitochondrial disease from families who have been blighted by it for generations. On the other hand, we are grappling with serious moral, legal and ethical questions that are raised by the proposed introduction of such techniques for treatment. We on this side of the House have a free vote. Speaking for myself, and myself alone, I will vote in favour of the regulations.

The noble Earl, Lord Howe, will respond to many important points that have been raised, but I ask him to focus on a number of very important considerations that have also been raised. On the question of continuing research and the comments of the expert panel, will he confirm that the panel said there was no evidence to suggest that the techniques proposed in the regulations are unsafe? Will he also confirm that the panel has agreed that further research and reviews could take place either before or after the regulations are approved?

As regards whether this matter is being rushed through Parliament and would benefit from further scrutiny by a Select Committee, the question here is: what would be gained by delay? Will the noble Earl confirm that the principles that we are discussing were approved by Parliament in 2008 after thorough debate? I do not need to go over the work of the Nuffield Council on Bioethics or that of the HFEA and its expert panel because noble Lords have mentioned that, but I should comment on the 90-minute debate that took place in the House of Commons. I agree with the noble Lord, Lord Alton, that 90 minutes is too short. However, I have read that debate and it seems to me that it was thorough and well informed and that the points on both sides were put forcefully and interventions were made. My honourable friend Luciana Berger was asked a number of very tough questions, as was the Minister. Could anyone say that at the end of those 90 minutes MPs were not in a position to come to a conclusion? Indeed, can anyone say that we are not in a position to come to a conclusion following a debate which has lasted at least three and a half hours?

We have heard from eminent lawyers on both sides of the argument on the legal questions. We have had written submissions from the Department of Health and the legal advice of the Wellcome Trust, and other legal propositions have been put to us. However, you reach a point when it is time to make a decision. I think that we are in a position to make such a judgment.

A number of noble Lords, including the noble Lord, Lord Alton, referred to the two techniques and how one should be considered in relation to the other. I understand the point that the noble Lord, Lord Alton, made. However, will the noble Earl, Lord Howe, confirm that the panel believes that at present there is insufficient evidence to choose between the two techniques? Does he consider that that is still the Government’s position? The noble Lord, Lord Deben, said that this was a question of resources. I have not seen evidence to suggest that that is the case. The important question is: can the Minister refute that? Can he say that the sole issue is that at the moment we are not in a position to judge which technique is likely to be more effective, and that it is solely for that reason that we are permitting the two techniques to be in the regulations?

Finally, we come to the position of the HFEA. At every point of our debates—this goes back to 2001—we have relied on the robustness of that body. The robustness of the HFEA is absolutely essential. There have been discussions and debates about how effective it is; my noble friend Lord Winston is a well known critic of some of its activities. Fair enough—but I believe that the HFEA has proved itself a highly effective and robust regulator over 20 years. I ask the Minister to confirm that it is the Government’s intention to continue to support the robustness of that regulatory approach.

As for the Chinese experience, will the Minister confirm that, although there are issues in connection with the techniques used, one big difference between the UK and the Chinese position is the regulatory framework and the robustness of the HFEA? I suspect that that was not the case in China years ago when those developments took place.

The question is whether the benefits of trying to eradicate this dreadful disease by preventing the transmission of mitochondrial disease, in view of the likelihood that otherwise children will continue to be born who will die in infancy, outweighs the risks of the techniques, which some noble Lords have described tonight. The scientific community—on the basis not of some kind of cosy consensus but of hard evidence—and the families experiencing this disease are clear that we are right to support the regulations. It is now up to us individually to decide whether we agree them. I, for one, am convinced that it is the right thing to do.

[Earl Howe]

My Lords—

[Baroness Scotland of Asthal]

My Lords, before the noble Earl starts his speech, may I apologise to the House? The noble Lord, Lord Alton, has clarified the fact that it was the Lord Chancellor and the current Attorney-General who voted against this measure in the House of Commons. I was told that two Law Officers had voted against, and I assumed that the two Law Officers must have been the right honourable Dominic Grieve and the current Attorney-General. It was not: it was the Lord Chancellor and the current Attorney-General. I should apologise for that; it was a misunderstanding of the information that I was given.

--- Later in debate ---

[Earl Howe]

My Lords, as I fully expected, this has been a debate of very high quality, with a range of views, both for and against the regulations, eloquently expressed. My principal job now is to respond to the Motion moved by my noble friend Lord Deben and to some of the additional points raised by other speakers.

My noble friend’s Motion covers three main points—safety, compliance with EU and UK law, and the key definitions in the draft regulations. My noble friend and the noble Lord, Lord Brennan, in his legal opinion, argued that there was some doubt about whether the regulations were compliant with EU law, in particular the EU directive on clinical trials. With respect to both noble Lords, the Government do not agree. The EU clinical trials directive does not apply here because it is concerned with medicinal products, and mitochondrial donation techniques simply do not fall under that definition.

My noble friend asked whether we had checked our position with the European Union. The simple answer is no. Within a framework of subsidiarity, it is entirely the responsibility of each member state to ensure that its own legislation is consistent with EU law. That is what we have done. The EU would be inundated with extensive queries from member states if a “legal advice” facility existed, and there is no such facility.

[Lord Gordon of Strathblane]

Is the noble Earl equally confident that the regulations are compliant with the European directive that is due to come into force in 2016, and which might explain the timing?

[Earl Howe]

My Lords, I think I can make an unequivocal statement that all the legal advice I have received is that the regulations we are considering are fully compliant with European law.

As has been said, any legislation agreed in Parliament could be subject to challenge, and it would be up to the Government at the time of challenge to defend their position. The noble and learned Lord, Lord Hope, made that point. Let me reassure noble Lords that we have considered these issues very carefully, and we are confident that the regulations are compliant. I am pleased that other noble Lords who have spoken agree with that.

The noble and learned Baroness, Lady Scotland, cited the European charter. The EU charter does not apply in this context, because Article 51 says that it applies to member states,

“only when they are implementing Union law”.

This means that a state must be either directly implementing an EU law obligation or acting within the scope of EU law. The regulations do not do either of those things.

We have considered the issues raised and, as I have said, we are very confident that these regulations do not contravene European law. The issue comes back to whether the clinical trials directive is engaged here. It is not. Our view, incidentally, was agreed with independent legal advice commissioned by the Wellcome Trust from Thomas de la Mare QC: mitochondrial donation simply does not come within the definition of medicinal products, to which the directive applies.

[Baroness Scotland of Asthal]

In the context of the horizontal articles of the charter, Articles 51 and 52, have the Government considered how Article 6.3 changes things, because it consolidates what the law was then? There is a difficulty, and I do not know whether the noble Earl has had specific advice on those matters. I know that this was not contained in the opinions that were promulgated earlier.

[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.