Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Viscount Ridley Excerpts

Tuesday 24th February 2015 Lords Chamber

[The Lord Bishop of Carlisle]

My Lords, for those among us—and I include myself—who are not scientists, this is a demanding topic. In fact, I guess that even those who are scientists do not always find it exactly straight- forward. A significant part of that complexity derives not from the difficulty of the science itself but from the different—sometimes diametrically opposite—things that we are told by people who have been studying and researching mitochondrial transfer for many years.

Like many others in your Lordships’ House, I have recently attended a number of presentations, drop-ins and seminars on this subject. I have also read through the many written representations that have been referred to and which most of us will have received. They mirror the speeches being made in this debate.

On the one hand, we are assured, as we have been today, that scientists are clear about both the safety and the efficacy of mitochondrial transfer. It is no different from giving a blood transfusion or changing the batteries, so there is no problem there. On the other hand, we are warned by scientists—not just the correspondents to whom my noble friend Lord Turnberg referred—that mitochondrial transfer is a form of genetic modification which does affect the germ line, albeit not the nucleus, and could have a potential impact on the traits of any children, and their children, born as a result of this procedure. Some suggest that this would involve crossing a key bioethical threshold that we could later regret, and we are all aware of the pressure that is being brought to bear on us from elsewhere in the world.

In addition to all that, from a purely ethical point of view, as my noble friend Lord Deben mentioned, one form of treatment, maternal spindle transfer, is for many people clearly preferable to the other type—pronuclear transfer. Unfortunately, as my noble friend Lord Patel pointed out, the spindle method is currently less stable, although that may change.

The so-called “genius” of the Church of England has always been its via media—the middle way—and that is where I find myself today. Over the last few years, we have consistently taken a fairly nuanced position on this subject. Despite some misleading press reports, we are not in principle opposed to mitochondrial transfer, and it makes a pleasant change for the church not to be against something. Indeed, I explained this to the Minister, Jane Ellison, before the debate in the other place and she referred to our conversation in her comments there. But, at the same time, we have always counselled a degree of caution, given the potential implications of this development. In particular, we have always argued that the research tests into safety—set out quite clearly as essential before any further move is made by no less than the HFEA expert panel in 2011— should be completed and reported before these regulations are approved. That has not yet happened. We are therefore disappointed by the element of rush now, which I guess could be occasioned by the forthcoming election. I was talking this morning with a GP friend, who said that she could not imagine any drug or treatment being authorised before all the necessary tests had been undertaken and reported. In this case, that clearly, according to the HFEA’s own recommendations, has not been achieved, even though, as we have been reminded, the research has of course been taking place for several years.

Like every other Member of your Lordships’ House, I am very keen to see help offered to couples who face the terrible prospect of a child born with mitochondrial disease. I also know which of the conflicting scientific viewpoints I would rather believe. To reiterate, both personally and as a representative of the Church of England I am basically very much in favour of this development. However, I cannot ignore the compelling arguments against pushing this through in haste, and for that reason I am minded to vote for the amendment proposed by the noble Lord, Lord Deben. I know that it is regarded by some as a wrecking amendment. I do not see, read or hear it in that way. I would hope that any Joint Committee’s work could be completed without undue delay. For the same reason, if we reach a Division on the initial Motion before us, I will feel compelled to abstain.

[Viscount Ridley (Con)]

My Lords, I must declare an interest in that much of the groundbreaking science of mitochondrial donation has happened at Newcastle University, where my wife also works, although in a different field. Also, some of the relevant work has taken place on the premises of the International Centre for Life in Newcastle, of which I am honorary president. I am also a fellow of the Academy of Medical Sciences.

I shall be as brief as I can. We have a duty to consider five simple questions. Is it legal? Is it safe? Is it necessary? Is it ethical? Is it rushed? It seems to me that, as the noble Lord, Lord Turnberg, said, we have clear evidence that it is legal for Parliament to enact these regulations. They are explicitly foreshadowed in the Human Fertilisation and Embryology Act 2008. They are not covered by the clinical trials directive. They are not eugenic, and therefore not in conflict with the EU Charter of Fundamental Rights.

Is it safe? We have heard that the safety and efficacy of both techniques have been established as far as is possible by exhaustive study, independent scrutiny and public consultation. The case of the Chinese example, as the noble Lord, Lord Patel, has said, is simply not relevant to this case. This was an obstetric disaster that happened to one woman and was a technique that was intended to cure infertility and had nothing to do with mitochondria anyway. As far as we can tell, the mitochondrial transplant element of that technique worked.

As for the infertility question, I have to say that I think my noble friend Lord Deben has misquoted a very distinguished scientist, Professor Robin Lovell-Badge. I was in the same meeting and I did not hear him say the words that the noble Lord said. He made the point that some techniques that are already legal and used probably perpetuate some forms of infertility. We therefore already accept that some techniques that are used may produce children who lead very happy lives but will themselves require assisted reproduction.

Incidentally, I completely agree with my noble friend Lord Deben that we should not argue from authority, that the consensus of scientists may sometimes be wrong and that we should make up our own minds. As always in science, however, it is the evidence, not the existence of a consensus, that convinces me that this is efficacious and safe.

Is mitochondrial donation necessary? If there is one thing that we have learnt from 30 years of in vitro fertilisation, it is that adoption is not a full alternative to conception. Were we right to give women assisted reproduction so that they could have their own children? Yes. Millions of happy mothers bear witness to that.

Is pre-implantation genetic diagnosis an alternative in this case? Often it is not, because it is more likely, as we have heard from the noble Lord, Lord Patel, because of heteroplasmy, to produce an afflicted child. I was also surprised to hear the noble Lord, Lord Deben, say that the reason we are going ahead with the techniques of maternal spindle transfer and pronuclear transfer is “about money”. I just do not think that is the case. It is very clear, as we have heard from the noble Lord, Lord Patel, and others, that there are very good reasons to go ahead with both these techniques.

Is it ethical? We do not, in the 21st century, have the luxury of deciding these things in a theological way. If we block an advance of this kind and it turns out that it could have eliminated suffering safely, then it is on our consciences in a way that it would not have been 30 years ago, when we could do nothing. In losing our impotence, we also lose our innocence. In other countries, this decision would be up to the regulator already. Here, uniquely, we have explicitly said that Parliament should first decide whether the regulator can take such cases, which is what we are deciding today.

Once Parliament has decided that mitochondrial donation is not likely to be unsafe, and the HFEA has judged that it is safe, it should be up to families to decide whether they wish to use it. It would be unethical for the state to deny them that choice.

We may become the first country to do mitochondrial donation, but there is nothing wrong with that. Britain has been the first with most biological breakthroughs, from natural selection to the double helix, from monoclonal antibodies to in vitro fertilisation. In every case, we look back and see that we did more good than bad as a result.

--- Later in debate ---

[Baroness Hollins]

My Lords, I do not think that intervention is very helpful as it is not relevant to the point I am making. The issue of heteroplasmy was spoken about earlier, and it simply means two or more different mitochondrial DNA types coexisting in a single cell. The review panel concluded:

“These levels may still not be sufficient to cause her children to have a problem, but subsequent generations could be affected”.

In paragraph 4.3 the panel stresses that,

“it should be accepted that there will always be some risk and unknowns associated with the use of MST or PMT in humans until it is tried in practice”.

I understand that and agree with it.

One argument for agreeing the recommendations now is to enable the HFEA to license these techniques as soon as it is convinced that there is sufficient evidence of safety without then having to seek parliamentary approval, thus possibly delaying implementation. In 2008, Dr Evan Harris, the former Member for Oxford West and Abingdon, a champion of the 2008 Act, said:

“Safety is clearly a concern… If Parliament decides that it is not safe enough to allow the HFEA to consider licensing something, Parliament would not draft, confirm or pass the regulations”.—[Official Report, Commons, Human Fertilisation and Embryology Bill Committee, 3/6/08; col. 35.]

Agreeing the recommendations now seems to be putting the chicken before the egg. Supporters of the techniques—

[Viscount Ridley]

The noble Baroness made the point that heteroplasmy, and therefore the carryover of the diseased mitochondria, is possible under this technique. Does she agree that experiments show that the likelihood is less than 5%, whereas pre-implantation genetic diagnosis has it at up to 40%? That is a legal procedure, so we are talking about trying to legalise a safer procedure than something that is currently legal.

[Baroness Hollins]

Again, I do not think that is the point that I am trying to make. Maybe I am not being quite clear enough.

Smoking: E-Cigarettes

Viscount Ridley Excerpts

Tuesday 3rd February 2015 Lords Chamber

Asked by

[Viscount Ridley]

To ask Her Majesty’s Government whether they will consider encouraging rather than discouraging the spread of vaping, in the light of the Cochrane review of e-cigarettes published on 17 December 2014 which found that e-cigarettes were more effective as an aid to quitting smoking than any other method.

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

My Lords, we recognise that e-cigarettes are being used by some smokers to help them cut down, or quit, tobacco. That is why the Government are already working towards a regulatory framework that ensures that they meet basic quality standards and are accompanied by sufficient information to enable informed choices. However, we would not wish to see children taking up vaping, as nicotine is a highly addictive substance. That is why we are also introducing a minimum age of sale for these products.

[Viscount Ridley (Con)]

I thank my noble friend for that encouraging Answer, but I hope that I can lure him into going just a little bit further. Given that 2 million people are vaping in this country, including a number of Members of your Lordships’ House, that 99% of them are smokers or ex-smokers and that the NHS says that vaping is 1,000 times safer than smoking and probably no more dangerous or addictive than coffee, does he therefore agree with me that it might be worth asking the Chief Medical Officer to look into how we can encourage this technology, given that it has a chance to do what patches, bans, health warnings and taxes have failed to do over decades, which is at last to consign the cigarette to the ashtray of history?

[Earl Howe]

My Lords, e-cigarettes are undoubtedly helpful to some people in enabling them to cut down on, or quit, smoking. The evidence is encouraging and we would not want to stop smokers trying out e-cigarettes as an alternative, particularly if other remedies have failed. Equally, we need to be cautious as regards the long-term health effects of using e-cigarettes. That is why the Chief Medical Officer is currently not able to recommend their use.

Smoking: E-cigarettes

Viscount Ridley Excerpts

Tuesday 17th December 2013 Grand Committee

[Viscount Ridley (Con)]

My Lords, I congratulate my noble friend Lord Astor, on securing this debate. It is an issue of much greater importance than the sparse attendance might imply and one that is growing in importance. I have no interest to declare in electronic cigarettes: I dislike smoking and have never done it. I have only once tried a puff on an e-cigarette, which did nothing for me. I am interested in this issue as a counterproductive application of the precautionary principle. I should say that I am indebted to Ian Gregory of Centaurus Communications for some of the facts and figures that I will cite shortly.

There are, at the moment, about 1 million people in this country using electronic cigarettes, and there has been an eightfold increase in the past year in the number of people using them to try to quit smoking. Already, 15% of ex-smokers have tried them, and they have overtaken nicotine patches and other approaches to become the top method of quitting in a very short time. The majority of those who use electronic cigarettes to try to quit smoking say that they are successful.

Here we have a technology that is clearly saving lives on a huge scale. If only 10% of the 1 million users in the country are successful in quitting, that would save £7 billion, according to the Department of Health figures given in answer to my Written Question last month, which suggest that the health benefits of each attempt to quit are £74,000. In that Answer, Minister said that,

“a policy of licensing e-cigarettes would have to create very few additional successful quit attempts for the benefits to justify its costs”.—[Official Report, 18/11/13; col. WA172.]

But who thinks that licensing will create extra quit attempts? By adding to the cost of e-cigarettes, by reducing advertising and by unglamorising them, it is far more likely that licensing will create fewer quit attempts. Will the Minister therefore confirm that, by the same token, a policy of licensing e-cigarettes would have to reduce quit attempts by a very small number for that policy to be a mistake?

Nicotine patches are also used to reduce smoking and they have been medicinally regulated, but there has been extraordinarily little innovation in them and low take-up over the years. Does the Minister agree with the report by Professor Peter Hajek in the Lancet earlier this year, which said that the 30-year failure of nicotine patches demonstrated how the expense and delays caused by medicinal regulation can stifle innovation? Does my noble friend also agree with analysts from Wells Fargo who this month said that if e-cigarette innovation is stifled,

“this could dramatically slow down conversion from combustible cigarettes”?

We should try a thought experiment. Let us divide the country in two. In one half—let us call it east Germany for the sake of argument—we regulate e-cigarettes as medicines, ban their use in public places, restrict advertising, ban the sale of refillable versions, and ban the sale of e-cigarettes stronger than 20 milligrams per millilitre. In the other half, which we will call west Germany, we leave them as consumer products, properly regulated as such, allow them to be advertised as glamorous, allow them on trains and in pubs, allow the sale of refills, allow the sale of flavoured ones, and allow stronger products. In which of these two parts of the country would smoking fall fastest? It is blindingly obvious that the east would see higher prices—and prices are a serious deterrent to attempts to quit smoking because many of the people who smoke are poorer than the average. We would see less product innovation, slower growth of e-cigarette use and more people going back to real cigarettes because of their inability to get hold of the type, flavour and strength that they wanted. Therefore, more people would quit smoking in the western half of the country.

What are the drawbacks of such a policy? There is a risk of harm from electronic cigarettes, as we have heard. How big is that risk? The Minister confirmed to me in a Written Answer earlier this year that the best evidence suggests that they are 1,000 times less dangerous than cigarettes. The MHRA impact assessment says that the decision on whether to regulate e-cigarettes should be based on the harm that they do. Yet that very impact statement says that,

“any risk is likely to be very small”,

that there is,

“an absence of empirical evidence”

and “no direct clinical evidence”, that “the picture is unclear”, and—my favourite quote—states:

“Unfortunately, we have no evidence”,

of harm.

There is said to be a risk of children taking up e-cigarettes and then turning to real cigarettes. Just think about that for a second. For every child who goes from cigarettes to electronic cigarettes, there would there have to be 1,000 going the other way, from e-cigarettes to cigarettes, for this to do any net harm. The evidence suggests, as my noble friend Lord Borwick has said, that the gateway is the other way. Some 20% of 15 year-olds smoke, and evidence from ASH and a study in Oklahoma suggests strongly that when young people use electronic cigarettes they do so to quit, just like adults do.

If we are to take a precautionary approach to the risks of nicotine, will the Minister consider regulating aubergines as medicines? They also contain nicotine. If you eat 10 grams of aubergine, which you easily could with a plateful of moussaka, you will absorb the same amount of nicotine as if you shared a room with a cigarette smoker for three hours. It is not an insignificant quantity. That is data from the New England Journal of Medicine in 1993. If we are worried about unknown and small risks, can the Minister explain to me why, as Professor Hajek, put it, more dangerous chemicals, such as bleach, rely on packaging and common sense rather than on medicinal licensing?

There has been approximately an 8% reduction in the use of tobacco in Europe in the past year. The tobacco companies are worried. A big part of that reduction seems to be because of the rapid take-up of electronic cigarettes. They are facing their Kodak moment—the moment when their whole technology is replaced by a rival technology that, in this case, is 1,000 times safer. Does my noble friend think that there may be a connection between the rise of electronic cigarettes, the rapid decline in tobacco sales and the enthusiasm of tobacco companies for the medicinal regulation of electronic cigarettes?

It is not just big tobacco; big pharma has shown significant interest in the regulation of electronic cigarettes. That is not surprising because they are, again, a rival to patch products and other nicotine replacement therapies. Perhaps more surprising is that much of the medical establishment is in favour of medicinal regulation. I never thought I would live to see the BMA and the tobacco industry on the same side of an argument. The BMA says that electronic cigarettes cannot be considered a lower-risk option, but this completely flies in the face of the evidence. As we have heard already, electronic cigarettes are 1,000 times safer. The BMA says that it is worried about passive vaping, the renormalising of smoking and the use of electronic cigarettes as a gateway to smoking. The excellent charity Sense About Science, to which I am proud to be an adviser, has asked the BMA for evidence to support those assertions. I must say that there is a strong suspicion that the only reason the medical establishment wants to see these things regulated as medicines is because it cannot bear to see the commercial sector achieving more in a year in terms of getting people off cigarettes than the public sector has achieved in 10. Instead of talking about regulating this product, should we not be talking about encouraging it, promoting it and letting people vape indoors if they want to—in pubs, on trains and in football grounds—specifically so that they are tempted to vape instead of smoke? That would be of enormous benefit to them and to the country as a whole.

I end by asking specifically in relation to the agreement that, as we heard from my noble friend Lord Borwick, was agreed last night, what its impact will be on what is happening, and in particular on advertising. As I understand it, under the agreement reached yesterday, it will be possible for the advertising of these things to be banned as if they were cigarettes. What is the justification for that, given the proportionality and the evidence that they will actually save lives rather than harm them?

--- Later in debate ---

[Earl Howe]

My Lords, that is probably the hardest question that my noble friend has asked me during this debate. My answer is that we certainly need to give careful consideration to that issue, which is about products that have the appearance of e-cigarettes but contain no nicotine. We would need to look at how common those products are or are becoming. Frankly, that work has yet to be done, but I am grateful to him for raising the issue.

I was speaking about our approach to the regulation of e-cigarettes, saying that we felt that proportionate medicines regulation was the best way forward. Nevertheless, we must consider carefully the views that have been forthcoming, including from the European Parliament, that there are alternative approaches to the regulation of e-cigarettes. Moving forward, the Government will want to be satisfied that the directive can deliver the right checks and balances on e-cigarettes. It is important to underscore the fact that there is a wide consensus across the European Commission, the European Parliament and European member states that additional regulatory safeguards are needed for this relatively new category of product. We are listening carefully to the genuine debate about how best to take this forward in the directive.

There is also emerging consensus that the advertising of e-cigarettes needs to be controlled. Options for doing so as part of the proposed European directive are under negotiation. In addition, the Committee of Advertising Practice, which writes and maintains the UK advertising codes that are then administered by the Advertising Standards Authority, announced in October that it intends to develop new rules to give clarity to advertisers and to ensure that e-cigarettes are promoted responsibly. It is considering running a public consultation on this issue early in the new year.

The Government’s priority during negotiations is to secure a directive that will reduce as far as possible how attractive e-cigarettes are to young people and closely to monitor the development of this market. When the directive has been settled, we will undertake an analysis to consider whether further action could be taken on a domestic basis, in particular to protect young people from e-cigarettes that contain nicotine. We also need to give further consideration to my noble friend’s question about non-nicotine-containing products, as I mentioned.

Regardless of how e-cigarettes are regulated within the proposed directive, we will still encourage the manufacturers of these products voluntarily to seek medicines licences for their e-cigarettes, so that they can be made available to support smokers to quit in the same way as other forms of nicotine replacement therapy, such as gum and patches. These e-cigarettes could be recommended for use in reducing harm, in accordance with the recently published public health guidelines.

[Viscount Ridley]

Has my noble friend taken on board the point that both I and the noble Lord, Lord Hunt, raised about the risk of regulation stifling innovation? By stifling innovation and slowing down the rate of take-up of these things, regulation could kill more people by preventing their coming off tobacco cigarettes.

[Earl Howe]

I most certainly have taken that point on board. I am grateful to my noble friend, who I hope will take some encouragement from what I said about our wish to see take-up of effective products. However, we need to be cautious about allowing products to flood the market that purport to contain certain quantities of nicotine and to deliver them safely but in fact do not. The safety and efficacy of these products are particularly important and we need to look at that.

Ageing: Public Services and Demographic Change Committee Report

Viscount Ridley Excerpts

Thursday 17th October 2013 Lords Chamber

[Viscount Ridley (Con)]

My Lords, it is a great privilege to speak after my noble friend Lord Borwick and to congratulate him on an eloquent and perceptive speech. I have known him for a little over a year but in that time we have become firm friends, despite the fact that we were briefly rivals on the hustings. He is, I venture to suggest, exactly the sort of successful and independent mind that the House of Lords most values. Indeed, I hope I do not cause offence if I say that there are probably not enough of us here who have such direct experience of manufacturing industry. He has developed batteries, reinvented electric vehicles, traded with China, run a foundry and metal powder group, employed thousands of people and, of course, was for over 20 years the man behind the famous London black cab.

I am sorry to trump my noble friend Lord Wei but, although my noble friend Lord Livingston became chief executive of a plc at the age of 32, my noble friend Lord Borwick did so at 31, albeit that the company was a slightly smaller one. It is curious that we should be trumping each other on youth in a debate about ageing. It was in that role, as he has said, that my noble friend Lord Borwick championed the idea of making the London taxi the first wheelchair-accessible public transport in the UK. This precedent enabled him to make the door ramps that transformed the London buses to become wheelchair-accessible too.

Successful as my noble friend has been, though, he has had his share of worries and challenges. He has mentioned today his two sons who needed complex heart surgery, and I know that he and his wife Victoria have thrown themselves into various medical and disability charities to enable others to cope with what life throws at them. I congratulate him on a fine maiden speech, and we look forward to many more contributions from him.

Turning to the topic of the debate today, and not wishing to take up too much of your Lordships’ time, I begin by saying that it is hard to remain an optimist after reading some of the things at the beginning of this report. We read phrases like “woefully underprepared”, see references to an inappropriate health model for England and are told that the current system is in trouble now. So, before making a more serious point, I would like to offer a tiny crumb of demographic good news—at least, I think it is good.

Although the number of 85 year-olds is going to double by 2030, as the report says, and although the number of people over 100 is increasing at the rate of about 7% a year globally so that there are now 500,000 people in the world over the age of 100, none the less there are just 60 people in the world over 110 and that number, if anything, seems to be going down. When the party opposite came to power in 1997 there were four people in the world over 115; today there is one. I am not sure who that reflects badly on.

The last time the global longevity record was beaten was in 1997 when Jeanne Calment died at the age of 122, and it will be at least 23 years until it is beaten again. The last time Britain’s longevity record was broken was in 1993—20 years ago—when Charlotte Hughes died at the age of 115. So something slightly odd is happening. Average lifespan is going up dramatically all the time, but maximum lifespan seems not to be changing much at all. As I said, it is a very small crumb of comfort as far as the issues discussed in this report are concerned.

I turn briefly to three of the report’s conclusions that I found most interesting and vital. The emphasis on a new model of healthcare to cope with this problem is crucial. We had a debate in this House a few months ago, which was initiated by the noble Lord, Lord Patel, on models of healthcare. I was very struck by how bipartisan the support was for fresh thinking on how we tackle healthcare. We have to be able to get beyond the sterile debate about whether it should be public or private and realise that it is bound to be a mixture of both.

The second, which the noble Lord, Lord Filkin, mentioned in his speech, is the importance of drawing on the assets of the elderly to support their care. This is not an easy subject, and it is one that many people have struggled with. I do not pretend to have the answer, but it is vital to have raised this matter and to be able to discuss it again, I hope in a bipartisan way.

The final thing is the vital importance of economic growth, because if we redoubled our efforts to increase the growth rate of this country, some of these problems would suddenly look a lot less insoluble. Nothing does more to make debts affordable than economic growth. If this country were suddenly to find a way of growing at 5% a year, it would double its economy in 14 years. On that note, I draw the attention of the House to the possibility that what we need to be doing is looking at the wider economy as a whole as a way to solve this problem.

Tobacco Products Directive

Viscount Ridley Excerpts

Tuesday 15th October 2013 Lords Chamber

[Earl Howe]

The noble Baroness makes a very good point. While some in the public health community are concerned about slim cigarettes, and understandably so, both the European Parliament and the Council decided that slims should not be banned under this directive. However, she is right that slims are known to be more attractive to women than men. It may be something that remains on the agenda for future consideration at a European level.

[Viscount Ridley (Con)]

My Lords, is the Minister aware of evidence from New Zealand that e-cigarettes are extremely effective in getting people off tobacco cigarettes and that they are more effective than tobacco patches? Is it not important that in regulating e-cigarettes we do not discourage them from taking a considerable market share from tobacco products, given that vaping is clearly much safer than smoking?

[Earl Howe]

My noble friend is right. E-cigarettes certainly have the potential for being a force for good in helping smokers to quit. At the same time, we do not want them to become a gateway into smoking. The aim is to have licensed products that have demonstrated safety, quality and efficacy, and for such products to be available as widely as possible.