Tobacco and Related Products Regulations 2016

Lord Callanan Excerpts

Monday 4th July 2016 Lords Chamber

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[Lord Callanan]

That this House regrets that the Tobacco and Related Products Regulations 2016 place restrictions on product choice and advertising of vaping devices, were devised before evidence had accumulated that vaping was enabling many people to quit smoking, run counter to advice from the Royal College of Physicians to promote vaping and are so severe that they could force vapers back to smoking and create a black market with harmful products; and calls upon Her Majesty’s Government to withdraw them (SI 2016/507).

[Lord Callanan (Con)]

My Lords, the issue of vaping and the tobacco products directive gives me a curious sense of déjà vu. Before I arrived in this House I was a Member of the European Parliament where, alongside a number of other MEPs from many varied parties and nations, I also opposed these restrictions. We made some improvements to the text but we were unsuccessful in our aim of removing vaping devices from the directive altogether. I never imagined at the time that I would have an opportunity to return to the issue in this House.

Eight weeks ago a number of us gathered in the Moses Room to debate a Motion on this subject tabled by my noble friend Lord Ridley. Everyone who spoke in that debate—including, to his enormous credit, the Minister—expressed considerable concern about these regulations. Since it was self-evident that neither the Government nor the Opposition thought this was a helpful package of measures, I put down a Motion for a Prayer for annulment. No one likes these rules, so why implement them? I quickly realised that I was straying into controversial constitutional territory—although, given recent events, a mere fatal Motion in this House now looks like a rather inconsequential intrusion on the constitutional landscape of this country.

E-cigarettes are by far the most popular gateway out of tobacco for our nation’s 9 million smokers. Some 100,000 of us die every year from smoking; that is a Hillsborough every eight hours. As my scientifically literate friends will no doubt explain, it is the smoke that kills, not the nicotine. There is now emphatic evidence of how much safer vaping is than smoking. Numerous studies have shown that vaping is 95% safer than tobacco smoking. In the UK, 2.8 million people have either stopped smoking or reduced their smoking significantly as a direct result of vaping. Yet, given all that evidence, these regulations will reduce by 95% the number of products on the market, ban the stronger liquids favoured by many vapers and ban virtually all forms of advertising to prevent suppliers from recruiting new smokers to the vaping cause.

So how have we ended up with this crazy state of affairs? The Department of Health prides itself on being a “global thought leader” on tobacco, to use its words, and while the department has played a strong game on pure control measures, by which I mean the ban on public place smoking and the taxation of smoking, it has been little short of appalling on its approach to tobacco harm reduction, by which I refer to the development of much less harmful substitutes to smoking.

There are two particularly egregious failures on the policy treatment of these smoking substitutes. The first occurred when the Minister of Public Health was one Edwina Currie. In 1988, in a moment of unhelpful decisiveness, she pushed through a ban on a product commonly called snus. This is an oral tobacco product which is a bit like sucking a teabag of tobacco leaves, and if noble Lords have not tried it I would not recommend it. Four years later, the EU decided also to adopt a ban. The only exception to the ban is Sweden, which negotiated an opt-out in the run-up to its referendum on joining the EU. Being permitted in one EU country but banned everywhere else provides us with a perfect case study of harm reduction measures. Because of the widespread use of snus, Sweden has by far the lowest smoking rate in Europe: 11% compared with the EU average of 26%. All the major forms of cancer are far lower, with the lowest disease rates correlating with the highest use of snus. The European Journal of Epidemiology has estimated that 200,000 lives could be saved every year if the EU had the same male smoking prevalence as Sweden, yet the product is banned because of us.

A second major blunder has been of course with the much more modern substitute of e-cigarettes. Here the Department of Health’s medicines agency, the MHRA, tried to ban them outright in 2010. It failed, so it tried again in 2013, declaring that they should all be medicines. Despite its opposition to commercially regulated e-cigarettes, the MHRA has failed to get even one medicinally regulated e-cigarette on to the market during the past three years, whereas the commercial market has so far managed to produce about 25,000 product varieties.

The 2.8 million vapers using those products are not smoking literally billions of deadly tobacco cigarettes. Displaying a marvellous gift for understatement, the Royal College of Physicians this year declared that the MHRA’s policy had been “counterproductive to public health”. However, in 2013 the Department of Health lobbied vigorously in Brussels for a Europe-wide policy of compulsory medicinal regulation. While I and my former colleagues in the European Parliament were able to ameliorate the policy, there was only a limited amount of change we could get through, hence the very flawed package that we are reviewing today. Economic modelling suggests that just one of the measures in it, the ban on stronger e-cigarettes, will cost more than 100,000 lives a year around the EU.

Not only was it a disastrous policy, it was also a disastrous policy process. In 2013 the then Public Health Minister, Anna Soubry, appeared before the European Scrutiny Committee to explain why she had decided to use a scrutiny override without informing other departments when she voted for this directive on behalf of the UK Government. The Minister told the committee in her evidence that e-cigarettes had in fact been excluded from the directive. They had not. If noble Lords can cope with viewing that cringe-making performance, it is, as they might imagine, widely available on YouTube. That level of competence was not just available at ministerial level. The Chief Medical Officer declared to the New Scientist a few months later that e-cigarettes were one of the three biggest health threats to the UK, along with obesity and binge drinking. It would be funny if the issue were not so serious.

What are the lessons of these two major policy errors by the Department of Health, which are costing us thousands of lives in this country? The first is the need for strong political leadership in the department. It is no good for the Secretary of State, who has presided over this latest debacle, to keep his head down. The new Prime Minister needs to recruit a real talent for the role of Minister for Public Health.

The other issue that needs to be looked at very hard is the role of the MHRA in policy development. It is a fact that this agency derives most of its revenue from the pharmaceutical industry. It is also clear that it has lobbied very hard for a land grab on e-cigarettes, yet has signally failed to deliver with any product available for consumers. Ministers should be extremely cautious about listening to its lobbying.

Let me give the House my favourite example of the way in which the MHRA is implementing the regulations. Many suppliers sell refillable e-cigarettes that are sold empty, ready for consumers to use their own e-liquid in them. A number of retailers told me that the MHRA had instructed them to affix warning labels to these products saying that they contain nicotine, which of course they do not at the point of sale. I assumed my correspondents were exaggerating and had got their facts wrong, so I obtained a copy of the official MHRA guidance. Let me quote from the section headed “Labelling your Product”:

“If your product does not contain nicotine when sold, but can be used to contain nicotine, the warning statement ‘This product contains nicotine which is a highly addictive substance’ must still be applied”.

It helpfully goes on to state:

“To provide clarity for consumers, we recommend adjacent wording (not part of the boxed warning) to the effect that the warning applies when the product is used as designed and … filled with nicotine-containing liquid”.

In other words, first, they must falsely label the product as containing nicotine when it does not, and then they must clarify for consumers that the product will contain nicotine as soon as they put some nicotine liquid in it. I do not know whether to laugh or cry at the MHRA, but in my view passing such regulations brings the law into serious disrepute.

Bizarrely, while the department is doing its best to restrict sales of one tobacco substitute, which costs taxpayers nothing, we are heavily subsidising nicotine-containing gum and patches, because they are given out on prescription. The difference, of course, is that these products are made by the big pharmaceutical companies, which appear to have the Department of Health as a sort of wholly owned subsidiary. These companies stand to lose large amounts of money as sales of their nicotine substitutes have collapsed with the advent of e-cigarettes. The pharmaceutical industry uses its massive spending power to manipulate the harm reduction debate. It funds conferences, so-called medical charities and quasi-academic research to justify its position. If the Department of Health is to improve its performance on tobacco harm reduction, it needs to be just as cautious in its dealings with pharmaceutical companies and their allies as it is with the tobacco industry.

This poverty of performance by the Department of Health led my noble friend Lord Prior to confess to the House that, if it had not been for the moderating effect of Brussels, the new regulations could have been “far worse”. This is a very difficult issue for a Brexiteer such as me to confront. Certainly, and somewhat unjustly, the EU has been on the receiving end of anger over the e-cigarette regulations. One poll found a very large majority for Brexit among vapers, who said they were angry with the regulations because of what they perceived to be the excessive influence of the big companies. Some of my noble friends might even wonder whether Anna Soubry in her role as Minister for Public Health was a sleeper agent for Vote Leave.

Where should policy go now? Although contrition from the Minister would be welcome, the key is to take concrete steps to improve the situation. Critical issues to which I ask the Minister to respond this evening include measures to rebuild consumer confidence in e-cigarettes. Smokers who do not currently vape perceive e-cigarettes to be much more dangerous than scientists say they in fact are. We need serious action, not just a few warm words. We also need a clear plan to put into production medicinal supplies of the stronger e-liquid used by a quarter of a million vapers, including my noble friend Lord Cathcart. It would be unconscionable if the MHRA were to fail on this once again. The need is simple: several suppliers of base e-liquid should be approved by the MHRA before Christmas.

--- Later in debate ---

[Lord Callanan]

My Lords, first I thank all noble Lords who have contributed to the debate this evening. It has been a fascinating and instructive debate. If nothing else, it has given me the opportunity to go into the Content Lobby for the first time in my parliamentary career in this House. I am normally quite a loyal government Back-Bencher. It has been an interesting debate. I do not agree with many of the conclusions given by the Minister that these regulations are proportionate and not over the top. They are totally disproportionate and totally over the top.

Let me clear up a couple of confusions that have arisen. First, I have no problem with the vast majority of these regulations. All of the regulations relating to the regulation of normal tobacco products I completely support. It is only the sections on e-cigarettes which I think are wrong. The clue is in the name. E-cigarettes are not tobacco products. They should not be in this directive in the first place. I argued this when it was originally proposed in Brussels. Of course, given the nature of regulations, it is not possible to amend them just to take out the electronic cigarette part without regretting the whole thing. In response to people who have made points about the main parts of the regulations, I agree. I support them, and as far as I know all of my colleagues who supported me also support those bits of the regulations.

Secondly, a number of arguments have been made about the big tobacco companies. I am entirely convinced that the big tobacco companies would support these regulations as they are for the simple reason that at the moment the e-cigarette vaping market is dominated by small and medium-sized enterprises. The costs of regulation that are going to be imposed by this directive are considerable. The big pharmaceutical companies and the big tobacco companies will be able to bear the costs of that regulation. They will buy up, as they are indeed starting to do, a lot of the little companies, and they will be able to bear the costs of regulation.

It was a great revelation to me when I first arrived in the European Parliament. I had naively assumed that business would be opposed to regulation. Actually, most big business thinks that regulation is a great thing. The chairman of a big pharmaceutical company once told me that it enables it to get rid of what he called “free riders”, in other words, small companies that were taking his market share, but did not have big corporate compliance departments and big lobbying and PR operations. I am entirely convinced that approving this regulation is to the benefit of big pharmaceutical and tobacco companies. Given all that, and given the indications from many Members of this House that they will not support the remainder of my Motion, I beg leave to withdraw it.

Motion withdrawn.

Tobacco and Related Products Regulations 2016

Lord Callanan Excerpts

Tuesday 10th May 2016 Grand Committee

[Lord Callanan (Con)]

My Lords, I, too, pay tribute to my noble friend for introducing this debate. I have a great sense of déjà vu because I was one of the people in the European Parliament that he referred to, who helped achieve the original decision against this directive’s restrictions on e-cigarettes. I was also the shadow rapporteur for my group and part of the European Parliament negotiating team that sat until about 11.30 pm in the Berlaymont, with the Commission chairing the meeting and the Council on the other side of the table, thrashing out the messy compromise that we see before us now in the tobacco products directive. Again, I have no difficulties with the vast majority of the directive; my concern was with the articles on e-cigarettes.

Before I started working on this, I had no particular knowledge of the subject. But when any dossier is placed before you, the first thing you do is read the various publications available and listen to all the lobbying and advice and you are also contacted by constituents. I was first alerted to the issue when my email inbox started filling up with literally hundreds of emails from people all over the country—and, indeed, Europe—concerned that these magical devices they had used to give up smoking were going to be banned or severely restricted. Together with a number of MEPs from all sides—including members of both the Liberal Democrats and the Labour Party in the UK—we started a campaign to improve the directive.

I have to say that we were not particularly helped by Department of Health officials. I tried to speak to Ministers many times to find out who was behind the restrictions and why there was such a campaign against something which so self-evidently provides great public health benefits and harm-reduction measures, but I never got a clear answer. I was pointed to a recording of a former public health Minister appearing in front of the European Scrutiny Committee of the House of Commons. When she was asked why she voted for this directive on behalf of the Government, she turned to her officials and said “I think the e-cigarette provisions were removed from it, weren’t they?”—which showed a worrying lack of understanding of what she was voting for on behalf of the Government.

Nevertheless, we ended up with this directive. It was a messy compromise and it is very badly worded, but it is a lot better than it could have been had we not campaigned on it. My noble friend Lord Ridley is quite right to point out the somewhat murky role of various pharmaceutical interests in the production of the directive. When I asked questions in the Commission and the Council—it seemed to me self-evident that these devices were brilliant for reducing tobacco smoking, which I thought was what we all wanted—I asked why they were even in the directive in the first place, given that it is called a tobacco products directive and e-cigarettes are not tobacco products in any sense of the word. The answer I received many times was that this was argued for by the pharmaceutical industry, which would have an awful lot to lose if e-cigarettes supplanted or replaced nicotine patches and gum. I do not know the truth of that, but it seems that it was very successful in getting what it wanted.

I completely agree with all the points made by my noble friends, but I have two additional points to make. First, on advertising, the Royal College of Physicians has a proud history at the heart of tobacco control. Since its first report, Smoking and Health, in 1962, it has been an intellectual leader in the field and is worth listening to. When the headline on the press release on its latest report states in bold,

“Promote e-cigarettes widely as substitute for smoking”,

one would hope that the Government would get the message that its 21 world-renowned authors are trying to put across. But we would be wrong if we thought that, for the regulations that the department wants us to approve are not about the promotion of e-cigarettes but about the suppression of information about them.

Paragraph 176 of the department’s impact assessment forecasts that the EU rules will reduce e-cigarette advertising by 90%. How are smokers supposed to hear about e-cigarettes? In paragraph 167, the department nonchalantly claims that cutting advertising will in fact not reduce the number of smokers switching to e-cigarettes. We have heard this old argument many times before—not from health officials but from tobacco company executives trying to pretend that advertising smoking would somehow not increase the amount of smoking.

The messages that we give really matter. In the complex decisions that smokers make every day about whether to smoke or consume nicotine through much cleaner forms, their perceptions of the relative risks of these products are crucial. The Royal College of Physicians, Public Health England and Action on Smoking and Health have all raised deep concerns about how smokers perceive e-cigarettes to be much more risky than they actually are. It is very interesting that Action on Smoking and Health should now say that, because I recall that that was not the message that it was giving when we dealt with the directive.

We are certainly not going to give that message by banning 90% of advertising, nor by insisting on e-cigarette packaging carrying big health warnings, which is what the Government are asking us to approve in these regulations. The Royal College of Physicians described the imposition of these warnings as “illogical”, bearing in mind that nicotine patch boxes do not have to warn of the dangers of nicotine.

Much of the problem stems from media reporting of junk science. The worst example was a headline in the Telegraph in December, which screamed:

“E-cigarettes are no safer than smoking tobacco”.

It was a nonsense report based on, as I said, junk science.

The second point that I want to raise concerns novel tobacco products. A number of new products have been introduced in this category, particularly products called “heat-not-burn”. These are very interesting developments, and a range of other alternative products is also in development. Some of the ones coming to market contain tobacco, but they work by heating it and not burning it. The absence of combustion is key. We all know that, as my noble friend Lord Ridley has said, harm from smoking comes primarily through the toxins produced by the burning of tobacco. In 1976, Professor Michael Russell wrote:

“People smoke for the nicotine but they die from the tar”.

That was reflected in the title of the recent study by the Royal College of Physicians on e-cigarettes, Nicotine without Smoke. With such technological developments, and a new regulatory basis with the introduction of the TPD, are the Government looking at the opportunities to be had from the available range of products, in addition to e-cigarettes, as part of a harm reduction agenda in the new tobacco control plan?

This is truly a terrible piece of legislation, and I plead guilty for the part I played in helping to produce it in the first place. However, it is not too late to undo some of that harm and to help encourage the taking up of e-cigarettes and, consequently, a reduction in tobacco consumption. Instead of trying to restrict e-cigarettes, the Government should in fact be trying positively to encourage them.