Question for Short Debate
16:00
Asked by
Viscount Astor Portrait Viscount Astor
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To ask Her Majesty’s Government what is their policy on regulation of the sale, advertising and promotion of e-cigarettes.

Viscount Astor Portrait Viscount Astor (Con)
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My Lords, electronic cigarettes are tubes that simulate the effect of smoking. Some e-cigarettes contain nicotine, but importantly they do not contain tobacco. Inside an e-cigarette is a small computer chip, a lithium battery, a heating element and a cartridge filled with water containing dissolved pharmaceutical-grade nicotine. You take a puff and the heater fires up the element to around 150 degrees centigrade, which heats the liquid in the cartridge so that it can evaporate. You inhale and that gives a so-called nicotine hit. You then exhale what looks like smoke but is in fact water vapour. E-cigarettes are regarded by some as a new and dangerous nicotine habit, but by others as a successful way to quit smoking. The truth is perhaps somewhere in the middle, but it is clear that e-cigarettes are here to stay. The market is expected to grow from £1 billion this year to £10 billion over the next five years. It is unregulated at the point of sale in this country, as it is in most countries worldwide.

There has been a recent attempt by the European Commission, which introduced a draft directive, backed by this Government, to regulate electronic cigarettes as medicines, but the proposal was thrown out by the European Parliament. A majority in the European Parliament supported using a mixture of tobacco regulation, controls on promotion and the reporting of adverse reactions. I understand that negotiations are continuing right up to today, and I hope that the Minister will be able to give us notice of any progress.

The Government have encouraged e-cigarette producers voluntarily to seek a licence for their products so that they can meet standards of safety and quality and be sold on prescription. Can the Minister say how many of the companies that produce and sell e-cigarettes have signed up to the voluntary code, and how many are estimated not to have signed up? Perhaps he could also confirm what the cost of validation might be for producers complying with a medical directive. I understand that it would be more than £250,000. This would put most of the smaller suppliers out of business and hand the industry over to the large tobacco companies, thus perhaps stifling competition.

As one drives into London on the M4, one can see three new vast advertising hoardings promoting e-cigarettes. Do the Government approve of this kind of advertising, which would not be allowed for normal cigarettes? There is a difficult issue here because most e-cigarettes are made up with 5% nicotine, but some, probably 10% of the market, have no nicotine in them at all. They are, for example, cherry or bubblegum flavoured. Some look like cigarettes and some like pencils, while others look like a pipe end without a pipe. If they wanted to regulate, how would the Government regulate an e-cigarette that contains no nicotine? Indeed, is it an e-cigarette, is it a toy or is it something else?

At the moment, e-cigarettes can be sold to children. Does the Minister believe that there should be an age limit, or will we see school playgrounds full of puffing children—or perhaps I should say even more full of children puffing? If so, would it be illegal for them to puff an e-cigarette that does not contain any nicotine? After all, what comes out of an e-cigarette is just harmless vapour, not smoke. Most e-cigarettes are made in China, with the nicotine and other flavours mainly being manufactured there. Is there any form of inspection regime for the importation of this nicotine additive?

There is evidence from America that e-smoking is on the increase, but not necessarily that e-cigarettes are a gateway to smoking, although it is estimated that the US has around 2.5 million users. We do know that nicotine is an addictive drug, and this new invention could set some on the path to nicotine addiction, but that is nicotine in very small amounts, which is hardly harmful in comparison with the danger of and damage caused by smoking. E-cigarettes could save the lives of millions of smokers by weaning them off normal cigarettes. They are a welcome aid to smokers trying to quit; for example, those who have failed with nicotine chewing gum or the patches. The value of the health gains associated with a single successful quit attempt is very substantial, and the Government’s own Department of Health estimates it at more than £70,000.

This is the dilemma facing health experts, policymakers and regulators—and, indeed, the Minister. There is very little research on the effects of e-cigarettes. While they are definitely less harmful than normal cigarettes, they contain carcinogens and toxic chemicals, albeit in very small quantities. E-cigarettes have been described as,

“the triumph of wishful thinking over data”,

and,

“an opportunity to improve public health”.

Closer to home, ASH—Action on Smoking and Health—supports the use of licensed nicotine products as an aid to cutting down or quitting smoking, and as a substitute for smoking. They satisfy the desire to smoke, help cut down on cigarettes and, of course, eradicate the smell of stale smoke and the effect of passive smoking on anybody nearby. Most diseases associated with smoking are caused by inhaling smoke, which contains thousands of toxic chemicals. As I have said, by contrast, nicotine is relatively safe.

My final question to my noble friend the Minister is: do we have to wait until the European Commission and European Parliament finally agree—if they ever do—or can the Government introduce sensible regulations on the advertising, promotion and sale of e-cigarettes? If the Government overregulate the sale of e-cigarettes and restrict their use, they will increase the costs to health in this country and miss an opportunity to cut down on smoking.

16:06
Lord Borwick Portrait Lord Borwick (Con)
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My Lords, first, I declare an interest as a trustee of the British Lung Foundation. Lung disease can affect everyone but it seems to be particularly prevalent in the poorest parts of the country. Of course, heavy smoking is strongly correlated with poverty.

Tobacco is by far the largest cause of lung disease, and a very large number of people suffer debilitation and a painful death because of it. I have many friends who have spent their lives trying in vain to help people addicted to cigarettes, and it is understandable that they passionately hate anything to do with smoking, including e-cigarettes.

When I visited the Consumer Electronics Show in Las Vegas, which I think is the largest trade exhibition in the world, in January this year, I saw about 200 Chinese manufacturers of e-cigarettes open for business. There is a tide of these things coming. They were the most common new product at the show after iPhone cases. One could wish that they would just go away, but of course they will not. So I congratulate my noble friend Lord Astor on opening this debate. Many people have been wishing e-cigarettes away; this is a useful chance to debate them.

People are addicted to nicotine but it is the tar that kills them. This seems well established. However, part of the addiction to cigarettes is not just the chemical nicotine but the handling of a cigarette, the sociability and the feel of it. Certainly, e-cigarettes provide a substitute for some of these sensations. They seem a reasonable and less dangerous product than conventional cigarettes.

The trouble is that we are fighting the battle against the killer tobacco on three fronts: on cost, by increasing consumption taxes; with education at earlier stages to ensure those likely to start smoking, namely teenagers, are aware of the risks involved; and by making cigarettes abnormal, by keeping them locked behind shutters at the supermarket and with other proposals such as plain packaging. It seems that the third front, denormalisation, is at least as powerful as the other two. The concern is that e-cigarettes can undo a lot of the good work that has been done to make smoking an unusual habit and smokers akin to pariahs. If it is okay to smoke e-cigarettes, will it become okay to smoke normal ones again? Will users ever kick the habit of enjoying nicotine and holding a cigarette?

Another important question must be addressed: what are e-cigarettes? Do they contain just nicotine and vapour, or anything else at all? This seems to call for regulation as a simple product, to ensure quality. Will my noble friend the Minister encourage his department to sponsor some research into the effects of nicotine alone? It is said to be dangerous to those with a heart problem or to pregnant women, but the truth is that there has not been enough research on the subject to be sure.

It is important to understand how e-cigarettes are changing the behaviour of smokers of conventional cigarettes. ASH has reported that as many as 1.3 million people occasionally use e-cigarettes and that 400,000 people are using e-cigarettes in total or partial replacement of normal cigarettes. That is great news.

The danger people spot is that children might become more likely to take up normal cigarettes after trying e-cigarettes. We cannot tell if that is so, because there has been not been any research on it, but logic suggests otherwise. Teenagers smoke cigarettes to look cool, and e-cigarettes are not cool—they are about giving up an addiction. No teenager wants to look as though they are giving up something: they want to look as though they have no problems.

According to research from the Institute of Economic Affairs from July 2013:

“Far from acting as a gateway to smoking, all the evidence indicates that e-cigarettes are a gateway from smoking”.

Evidence from ASH supports that statement. Indeed, the fact that 400,000 people have given up cigarettes is great news, and if we concentrate on that, we should say that there should be no real restriction on the sale or advertising of e-cigarettes. If they are mainly used by existing smokers as a way of quitting, we could even do good by giving them away to smokers.

If we are to have any regulation, it should be of the quality of the contents alone: restricting the ingredients to nicotine; ensuring damaging toxins are kept out of them; and not allowing flavoured e-cigarettes specifically designed to attract children, such as bubblegum e-cigarettes or such like.

In choosing today for this short debate, my noble friend Lord Astor has shown a downright astonishing ability to predict the future, because a provisional deal was reached last night in Brussels between MEPs and national Governments on a new tobacco products directive. Martin Callanan MEP has said that this directive will take the majority of e-cigarettes off the market. It would restrict all but the weaker e-cigarettes, even though smokers who are considering using e-cigarettes to break their addiction tend to begin on stronger e-cigarettes and gradually reduce their usage. Making stronger e-cigarettes harder to come by will encourage smokers to stay on tobacco. Among the points made in the draft directive, paragraph 3.7 states that its purpose is to stop the situation whereby,

“more people—unaware of the content and effects of these products—inadvertently develop a nicotine addiction”.

The idea that somebody will inadvertently become addicted without the help of the EU seems rather unlikely.

Finally, I pose a conundrum for the Minister. If we go ahead with plain packaging for cigarettes—which are actually illustrated with lurid photographs of health problems—do we allow e-cigarettes to be sold in similar packages if the manufacturer wants to? That is something that the great Sherlock Holmes might perhaps describe as a “three pipe problem”.

16:13
Viscount Ridley Portrait Viscount Ridley (Con)
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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?

16:22
Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab)
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My Lords, first, I apologise to the Committee for being a little late for the start of the debate. I welcome this debate and I congratulate the noble Viscount, Lord Astor, on allowing us to discuss a very interesting subject. I am sure that we are all looking forward to the noble Earl’s response to the many questions that have been put to him.

With more than 100,000 people dying from smoking-related diseases across Britain every year, it is clear that we need to do all we can to support people to give up smoking and discourage young people from taking it up in the first place. One thing I am convinced about is that e-cigarettes have the potential to provide a significant boost to public health. I understand that the National Institute for Health and Care Excellence supports the use of nicotine-containing products such as e-cigarettes to aid smokers in cutting down on tobacco. As we have heard, an estimated 400,000 people across the UK have already switched from smoking to e-cigarettes.

I noted the comments of the noble Viscount, Lord Ridley, on the risks of regulation, and I agree with him that it is important that regulation does not stifle innovation. On the other hand, as with any new and fast-emerging product, some additional safeguards may be needed to cover any gaps in our existing consumer regulations. I want to ask the noble Earl, Lord Howe, about this. Does he consider that the medicinal regulation of e-cigarettes would put a lot of the current e-cigarette companies out of business? The noble Earl is of course very well acquainted with the work of the MHRA, issues to do with the regulation of medicines and, indeed, herbal medicines, which may be relevant in this context. I wonder if any work has been done to estimate the cost of regulation for these products.

For instance, I imagine that a dossier has to be produced with scientific evidence to show the efficacy and safety of these products. I wonder whether the noble Lord has an estimate of the cost of this, and whether that would inhibit many of the small companies in this market from being able to carry on in business when this is introduced. I support regulation that is light-touch and permissive rather than restrictive.

As the noble Viscount has said, the regulation of e-cigarettes has been debated as part of the EU trilogue negotiations on the tobacco products directive. Can the noble Earl inform the Committee of the progress of those negotiations? I understand that they are scheduled to end in the coming weeks, and an update would be appreciated, as would some sense of the timeline between agreement within Europe and the implementation of this proposed directive.

As the noble Lord, Lord Borwick, has commented, e-cigarettes have clearly been very successful in encouraging smokers to quit and to use e-cigarettes instead. He posed the question of whether there are circumstances in which e-cigarettes could be a passport to tobacco smoking. I think he talked about teenagers in particular, implying that some of the marketing approaches of the e-cigarette manufacturers might provide a cool image to young people, who would take up e-cigarettes and then be tempted to go on to tobacco products. I do not know whether the noble Lord, Lord Borwick, saw the complaints made about an advert for e-cigarettes screened by ITV on 3 December during “I’m a Celebrity”, which appeared to show a woman talking about oral sex, while at the end of the advert it was revealed to be a reference to e-cigarettes. The question I put to the noble Earl is: how do we ensure that e-cigarette manufacturers are not able to advertise in such a way as to make e-cigarettes attractive to young people who would not ordinarily have come to smoking, so that they act as a passport to tobacco smoking?

If the noble Earl can reassure us that regulation can be light-touch, that the process of being regulated as a medicinal product will not be overbearing, and that there can be appropriate controls on advertising, then we should welcome the impact of e-cigarettes, because the evidence is clear that they have helped a lot of people come off tobacco smoking. Surely, in the end, that is to be welcomed.

16:28
Earl Howe Portrait The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
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My Lords, I thank my noble friend Lord Astor for securing this important and highly topical debate.

As we have heard, e-cigarettes are nicotine-containing devices that work by atomising a nicotine solution which is then breathed in as a vapour by the user. E-cigarettes claim to deliver nicotine to the user without the toxins and carcinogens found in tobacco smoke. They do not involve any combustion and do not produce smoke. E-cigarettes are a very recent innovation. They are available in various shapes and sizes, as we have heard, and many are designed to both look and feel like conventional cigarettes. Some even incorporate a light at the end of the device that glows when the product is being used, to replicate a cigarette. Today, they are marketed as a cheaper and healthier alternative to smoking tobacco. However, e-cigarette manufacturers have avoided directly suggesting that their products are smoking cessation aids, as making such claims would subject their products to regulation as medicines.

I turn to whether e-cigarettes are safe to use. When we compare the use of e-cigarettes to smoking of tobacco, the Department of Health is confidently able to say that e-cigarettes are likely to be much safer to use. That does not mean that e-cigarettes are safe to use; it probably says more about how enormously unsafe it is to smoke tobacco. Nevertheless, the safety of e-cigarettes is yet to be fully established. Given how novel these products are, we need to see much more evidence about their safety, especially regarding the use of e-cigarettes over a long period.

At present, e-cigarettes are sold without any product-specific controls relating to quality and safety in use, or specific provisions on advertising and promotion. There are general product safety provisions that apply to these products, but they are not designed for these sorts of product and are not fit for this purpose. We also must keep in mind that nicotine itself is not only highly addictive but can be highly toxic. Electronic cigarettes are not risk-free. Known and reported health risks include acute effects on lung function, possible pneumonia and other risks related to poor product quality.

My noble friend Lord Astor made reference to Action on Smoking and Health. ASH says that there is significant variation in device effectiveness, nicotine delivery and cartridge nicotine content, both between and sometimes within product brands. ASH cites research that suggests the presence of toxins, released in low concentrations, from the vaporisation process involving certain e-cigarette cartridges. It cites other research that concluded that e-cigarettes have a low toxicity profile, are well tolerated and are associated only with mild adverse effects.

As we have heard during this debate, the e-cigarette market is growing rapidly. More than 300 companies are estimated to be importing or supplying e-cigarettes in the United Kingdom. The e-cigarette market in the UK is estimated to be worth in excess of £100 million, and we know that across the world the tobacco industry is becoming increasingly involved. There is little doubt that awareness of e-cigarettes has increased quickly through advertising and promotion of these products. It has been said that e-cigarettes are being promoted in similar ways to how cigarettes were promoted before we introduced a comprehensive ban on tobacco advertising in this country. I am sure that I am not alone in noticing the vast amount of promotion for e-cigarettes in my local convenience store, or the representatives of e-cigarette companies in shopping malls or outside train stations promoting their products.

The University College London smoking toolkit study is a national study of smoking and smoking cessation in England. The most recent data from the survey suggest that electronic cigarette use by tobacco smokers has increased from around 2% in 2011 to around 14% in August 2013. If this trend were reflected across the UK, it would translate to around 1.4 million smokers who have used electronic cigarettes. There is little evidence to suggest that non-smokers are becoming attracted to using e-cigarettes.

My noble friend Lord Borwick asked about the behaviour of children and young people. ASH commissioned research into the use of e-cigarettes by young people and found that, in Great Britain in 2013, 95% of 11 to 14 year-olds and 90% of 16 to 18 year-olds have never used e-cigarettes. Among young people, e-cigarette use appears to be confined to those who have already tried smoking. Nevertheless, we remain concerned that e-cigarettes could quickly become popular with young people, particularly if they continue to be vigorously advertised and promoted. We are also very aware of concerns expressed that e-cigarettes could act as gateway products for young people into smoking, and will continue to watch the evidence closely.

The Government recognised in the tobacco control plan for England that smokers are harmed by the tar and toxins in tobacco smoke, not necessarily by the nicotine to which they are addicted. There is no way of avoiding these deadly toxins if you inhale smoke from burning tobacco.

Earlier this year, the National Institute for Health and Care Excellence published public health guidance on harm-reduction approaches to smoking. The noble Lord, Lord Hunt, asked about this. NICE recommends the use of licensed medicines only. The guidance suggests that while the best way to reduce smoking illness and death is to encourage smokers to quit completely, there are other ways of reducing the harm from smoking, even though this may involve the continued use of nicotine. If someone does not want to, is not ready to or is unable to stop smoking in one step, the guidance suggests that licensed nicotine replacement therapies could be of use.

My noble friend Lord Borwick asked about the possibility of sponsoring research in this area. We already know quite a lot about the safety profile of nicotine and its use in cutting down and quitting. The evidence we have is that these products are used mainly to cut down and quit.

My noble friend Lord Ridley called for clearer evidence of effectiveness. The problem is that there is not good evidence of effectiveness. These products are not magic bullets, in other words, but even at this stage we feel that we want to exploit the potential that we see in them. He referred to aubergines as potential medicines. I think he would agree with me that people do not eat aubergines in the expectation that that will help them to quit smoking. Clearly, whatever remedy we encourage has to be effective in its ability to cut down and quit the habit of smoking.

There is potentially a place for e-cigarettes within a harm-reduction approach to public health, but only if they meet the requirements set out in the public health guidance; that is, if they are licensed medicines. I would expect that the NHS and health professionals would also only recommend the use of e-cigarettes that are licensed as medicines. My noble friend Lord Astor asked whether we envisaged e-cigarettes being sold on prescription. We want effective products to be widely available, not just on prescription but in general sale outlets such as supermarkets and corner shops.

The noble Lord, Lord Hunt, asked how much it would cost an e-cigarette manufacturer to get a medicines licence. The impact assessment that we published estimated that the annualised cost to a single UK e-cigarette importer for complying with medicines regulation ranged from £87,000 to £266,000.

I am particularly grateful to my noble friend Lord Astor for securing this debate because it provides me with the opportunity to explain to your Lordships the action that is under way to regulate e-cigarettes. As the Chief Medical Officer for England has said, since more and more people are using e-cigarettes, it is only right that these products are properly regulated to be safe and work effectively.

A European tobacco products directive was proposed late last year and is now in its final stages of negotiation in Brussels. I can tell noble Lords that no deal has yet been reached in the discussions but the Government hope that agreement might be reached shortly. I reassure your Lordships that the United Kingdom has been active during these negotiations, as we believe that the proposed tobacco products directive will benefit public health and help to reduce the number of young people who take up smoking in the UK.

From the outset, it was envisaged that e-cigarettes would be regulated within the proposed directive. Protecting and promoting public health has always been our starting point, and we want safe and effective nicotine-containing products that can help smokers cut down and quit. The Government took the view that proportionate medicines regulation was the best way to deliver that objective.

Viscount Astor Portrait Viscount Astor
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Does my noble friend consider that e-cigarettes that contain no nicotine at all but contain other flavours will or should come under the tobacco directive?

Earl Howe Portrait Earl Howe
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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 Portrait Viscount Ridley
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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 Portrait Earl Howe
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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.