Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Debate between Earl Howe and Baroness Scotland of Asthal

Tuesday 24th February 2015 Lords Chamber

[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 ---

[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.

Abortion (Sex-Selection) Bill

Debate between Earl Howe and Baroness Scotland of Asthal

Tuesday 16th December 2014 Lords Chamber

[Earl Howe]

I am sure that noble Lords around the House will form their own conclusions on the information provided by the noble Lord, Lord Alton, but I do give that undertaking.

[Baroness Scotland of Asthal (Lab)]

My Lords, is not one of the difficulties being faced by the practitioner the fact that the guidance talks about “alone”, whereas we know that the psychological issues which arise among women who are put under pressure to have only boys may count towards the rationale that produces the abortion? What, if anything, do the Government intend to do to address this issue?

[Earl Howe]

My Lords, coercion and violence is of course an issue that is taken very seriously. Every woman who is being seen for a possible abortion has the opportunity to speak to a healthcare professional on her own. Those healthcare professionals are trained to be alert to the signs of coercion and violence and will take appropriate action.

HIV: Late Diagnosis

Debate between Earl Howe and Baroness Scotland of Asthal

Monday 1st December 2014 Lords Chamber

[Earl Howe]

I shall have to take advice on the second question posed by the noble Baroness, which I do not know the answer to. But in answer to her first question, an estimated 107,800 people were living with HIV in the UK in 2013, of whom 24% were unaware of their infection, remain at risk of infecting others and are unable to benefit from effective treatment. That is why it is so very important that we target the at-risk communities to urge them to get tested, either in a clinic or through self-testing kits, which are now legal.

[Baroness Scotland of Asthal (Lab)]

My Lords, I wonder if the noble Earl can help me as to what work is being done in relation to women who are suffering from partner violence. Your Lordships will know that 12% of those involved in intimate romantic relationships have HIV through partner violence. Will the noble Earl say what the Government intend to do about that?

[Earl Howe]

The noble and learned Baroness is absolutely right. Those who are at risk of partner violence are of course at greater risk of contracting a sexually transmitted disease. We know this to be true particularly in countries overseas. The work to combat domestic violence, which the noble and learned Baroness is very familiar with, continues. It is vital, not just in this area of work but more generally in the field of mental health, to ensure that women at risk of violence—particularly women—have a place of refuge and a source of advice.

Public Health England Advisory Board Membership

Debate between Earl Howe and Baroness Scotland of Asthal

Thursday 4th July 2013 Lords Chamber

[Earl Howe]

The advertisements will go out, I understand, in September, with a view to making the appointments by the end of the year. As regards the gender balance, the noble Baroness may like to know that within Public Health England itself there are almost twice as many women and men across the workforce, and in senior roles there are more women than men. I hope noble Lords will understand that Public Health England itself has no gender bias. The key thing is that appointments are made in accordance with the published criteria on merit. It is our aspiration to have gender balance, but the criteria must be related to those issues.

[Baroness Scotland of Asthal]

My Lords, the Minister is dedicated to equality and understands very well the issues relating to female health, particularly as a result of the World Health Organisation report last month, which indicated that the greatest cause of morbidity in women and girls, in one case in three, is domestic violence. Can he therefore explain why the Government chose to have a board that has no women on it? That board cannot then reflect the reality of the health needs of our nation.

[Earl Howe]

We are very mindful of that, but I come back to the point that these appointments were made on merit in accordance with the published criteria. That is not to say that the unsuccessful candidates lacked merit, but we did not operate a policy of positive discrimination and I do not think that anyone would wish us to do that. Having said that, we are mindful in the department of the need to have gender balance whenever we can in public appointments. Our record is not bad; we are in the region of 44% of appointment rates for women appointed to public positions, which is quite high up in the departmental league table.

Health and Social Care Bill

Debate between Earl Howe and Baroness Scotland of Asthal

Wednesday 2nd November 2011 Lords Chamber

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

My Lords, this has been an excellent debate. It has proved one thing in my mind: an issue of this importance for the Bill—the overarching duty of the Secretary of State for the NHS—has benefited enormously from having a Committee of the Whole House to consider it. Without unnecessarily detaining the Committee, I hope it will be helpful if I say something on the record about each amendment.

I begin with Amendment 3, tabled by my noble friend Lady Williams, the noble Lord, Lord Patel, and the noble Baroness, Lady Thornton, and Amendment 5, tabled by the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt. Both amendments would have the effect of restoring the Secretary of State's current duty to provide services in Section 1 of the National Health Service Act. There has been extensive discussion of this both today and at Second Reading, so I shall not recap all the arguments. The core argument is that the duty to provide no longer reflects the practical reality of how NHS services are delivered or our proposals for the Secretary of State's functions in the new system.

Before I explain further, I should make clear that we are now discussing the Secretary of State's relationship with NHS services rather than his duties in relation to public health, where his direct responsibilities for provision remain firmly in place. In that context, I refer noble Lords to Clause 8 of the Bill. While I understand that many people are attached to wording that dates back to the founding Act of 1946, it is now more than 20 years since the Secretary of State had any direct responsibility for the provision of services. Only a tiny minority of NHS services—those still provided by PCTs —are carried out under the Secretary of State's delegated function of providing services. In future, all NHS services will be provided by NHS trusts or foundation trusts, both of which have their own self-standing powers to provide services and do not rely on the Secretary of State's duty to provide under Section 1(2), or by independent providers. The Secretary of State will have no powers to provide NHS services. That is the reality.

I am grateful to the noble Lord, Lord Warner, and to my noble friends Lord Newton and Lady Cumberlege for their persuasive arguments articulating the need to reflect this reality in legislation. As my noble and learned friend Lord Mackay helpfully explained, the Secretary of State has never had an unqualified duty to provide services; he has had a duty to provide or secure the provision of services. In recent years he has relied on the latter part of that duty to fulfil his functions, while the former part has ceased to have any practical relevance. I hope that that answers the question posed by the noble Baroness, Lady Jay.

There is another reason why it would be wrong to reinstate the duty on the Secretary of State to provide. Under the legal framework of the Bill, the Secretary of State no longer possesses powers to direct others to provide services. Therefore, unless we were to re-impose a system of regulations or directions by which the Secretary of State could delegate his duty to provide and control its exercise, which would risk replicating the micromanagement of the status quo, it is hard to see how this legal obligation to provide services could be fulfilled. For obvious reasons, it would be undesirable to create a situation in which the Secretary of State provided services himself. Also, in practice he would lack the capacity to do so, for example in terms of staff and facilities.

Instead, the duty we propose in the Bill is a more accurate reflection of what Ministers do. In line with policy that has evolved over two decades, the Secretary of State will not provide services or directly manage providers; nor will he have the powers to do these things. Instead, providers will be regulated independently. Rather than intervening in day-to-day decisions by local providers, the Secretary of State will have powers to hold to account the regulators, Monitor and CQC, for the way that they are performing their functions, and powers to hold the NHS Commissioning Board to account for the way that services are commissioned. In other words, the Secretary of State—

[Baroness Scotland of Asthal]

My Lords, I hesitate to intervene on the noble Earl, who knows I hold him in the highest possible esteem, but I think he is now treading on some contentious legal issues. Bearing in mind the wonderful consensus that we have now reached, I would just ask him to consider whether, at this stage, some of those issues are really helpful because the noble Earl will know that the Secretary of State does, by his servants, agents or otherwise, provide services and, indeed, there have been times when there has been a pandemic when the Secretary of State has had to make such provision. These are contentious issues which I am sure could intrigue us for many hours, but since we have happily come to the conclusion that we have had a surfeit of such happiness and wish to go forward, I gently say to the noble Earl that this might be a moment when we could swiftly do that.

[Lord Lester of Herne Hill]

My Lords, I would not have intervened otherwise, but I respectfully disagree with what the noble and learned Baroness, Lady Scotland, has just said. I am finding it very helpful to listen carefully for this reason: it seems to me that the Secretary of State must have a duty to secure the provision, as has been said by the Minister, for the purposes of giving effect to our international treaties, including those on human rights. Therefore, what he is saying at the moment is very important to me in trying to see how one can get wording that will include that as well.