Good news confirmed today: Swedish Match, the main European snus manufacturer, will take legal action to overturn the European Union ban on snus -see Reuters 1 July 2016: Swedish Match to challenge EU snus ban in UK court. This ban is possibly the most absurd and harmful piece of legislation the European Union has ever concocted, and its demise is long overdue.
The EU snus ban was introduced in 1992 (directive 92/41/EEC) and reaffirmed in 2001 (2001/37/EC) and reaffirmed again in 2014 in the Tobacco Products Directive 2014/40/EU Article 17. The ban only exists because of posturing by self-indulgent and negligent politicians backed by prohibitionist harm-inducing NGOs. It has no scientific, ethical or legal justification whatsoever (see Death by regulation: the EU ban on low-risk oral tobacco) and can only be causing harm to health by denying smokers elsewhere in Europe benign alternatives to smoking that work so well in Sweden.
In 2003, Swedish Match challenged the identical ban in the previous Tobacco Products Directive 2001/37/EC (Article 8) and failed. See Case C-210/03 before the ECJ. However, a great deal has changed since then and even in 2003/4 I think they were unlucky to face a politicised court and improper scientific assessments of risk pushed by anti-scientific prohibitionists. But why should a legal challenge succeed now when a challenge failed in 2003-4? There are at least ten reasons to believe it will succeed this time.
1. The strength of the harm reduction concept
In C-210/03 Swedish Match did not rely heavily on harm reduction arguments – i.e. that the product has had a net health benefit where it is allowed onto the market. The evidence was thinner and contested at the time, but scientific and policy case for tobacco harm reduction is much more established now – see for example the Royal College of Physicians, 2007, Harm reduction in nicotine addiction: Helping people who can’t quit and see the impressive data on Sweden: Ramström & Wikmans, 2014, Mortality attributable to tobacco among men in Sweden and other European countries: an analysis of data in a WHO report. A much more assertive case could be made today – not just that it is low-risk, but that snus, where permitted, has been positively beneficial for health. In its 2016 report, Nicotine without smoke: tobacco harm reduction, the Royal College of Physicians gives a clear endorsement of snus, and concludes the ban has caused harm in other snus-using countries:
The availability and use of an oral tobacco product known as snus in Sweden, documented in more detail in our 2007 report (and revisited in Chapter 7), demonstrates proof of the concept that a substantial proportion of smokers will, given the availability of a socially acceptable and affordable consumer alternative offering a lower hazard to health, switch from smoked tobacco to the alternative product. Particularly among men, the availability of snus as a substitute for smoking has helped to reduce the prevalence of smoking in Sweden,which is now by far the lowest in Europe. The magnitude of the contribution made by the availability of snus over and above conventional tobacco control measures is difficult to quantify, but a recent study of the effect of withdrawal of snus from the market in Finland in 1995, when both Finland and Sweden joined the EU, but only Sweden was allowed to continue its use, estimates that over the following 10 years the availability of snus reduced smoking prevalence in Sweden by an additional 3.7 percentage points. Trends in snus use in Norway are similar to, and perhaps stronger than, those in Sweden, and there the use of snus is strongly associated with quitting smoking. [see original for references]
2. Support from public health experts
There are now several public statements from experts supporting the lifting of the snus ban – including to the 15 scientists writing to Commissioner Dali in 2011 and another group to the UK Secretary of State in 2013 and a general statement in favour of ‘harm reduction’ including with smokeless tobacco from 53 experts in a letter to WHO Director-General Margaret Chan in May 2014. I have no doubt scientists with high integrity will now go on the record now to support lifting the ban and provide appropriate affidavits to the court if requested. There was minimal overt support for lifting the ban in 2003, and Swedish Match made the case without support from the scientific or public health community.
3. Official scientific report (SCENIHR)
The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) accumulated evidence regarding the role of snus in ‘harm reduction’ in Sweden and Norway in the SCENIHR report on smokeless tobacco in 2007, which is discussed in detail here. Despite apparently strenuous drafting efforts to avoid drawing the obvious conclusion about lifting the ban in the report headlines, the substance of the report strongly supports lifting the ban.
4. WHO expert endorsement for regulation
Reports from WHO’s TobReg expert committee argues that smokeless tobacco should be regulated, not banned, for example, WHO Study Group on Tobacco Regulation in its 2009 report ”
“Smokeless tobacco products should be regulated by controlling the contents of the products”
An elegant escape from the ban, and one that would improve products that are not currently banned, would be to regulate the toxicity of all smokeless tobacco products placed on the market in the EU- without discriminating, absurdly, between those that are sucked and those that are chewed (see definitions of smokeless tobacco and ‘oral tobacco’ in 2014/40/EC Article 2(5) and 2(8) combined with the selective ban on oral tobacco in Article 17).
5. The Swedish Match interaction with the US Food and Drug Administration
The FDA has already scrutinised Swedish Match’s public health case for snus in some detail. In November, the FDA granted a Pre-Market Tobacco Application (PMTA) for Swedish Match’s products, to allow a new snus range to be placed on the market in the US. The PMTA does not authorise a reduced-risk claim, but it does mean the product has been evaluated by the FDA as ‘appropriate for the protection of public health’. The FDA announcement of November 2015 states:
“Under the PMTA pathway, manufacturers must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health. That standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. […]
“The PMTA decisions for these products reflect evidence showing that these products, marketed as described in the manufacturer’s application, would result in a low likelihood of new initiation, delayed cessation or relapse. The FDA’s review also determined that these products would likely provide less toxic options if current adult smokeless tobacco users used them”
With this assessment, it is difficult to see how Europeans could make a case for a ban, especially when much of the evidence assessed by FDA comes from Europe.
This PMTA is part of Swedish Match’s larger effort to make a Modified Risk Tobacco Product (MRTP) application to the FDA. Swedish Match has made a case for changing warnings and supplied 130,000 pages of documentation to justify its position – see this summary of the MRTP case (45-page extract – PDF) – and this application has attracted support from independent experts and consumers. At the time of writing, the MRTP application has not yet been decided by FDA, but if approval is granted over the course of the case it will create a difficult comparison between US and Europe. In making its case to the FDA, Swedish Match has compiled a comprehensive and detailed case for the FDA – so it is likely to be better prepared than the UK government or European Commission to fight this case.
6. New provisions in the 2014 Tobacco Products Directive to deal with novel products
The inclusion in the new Tobacco Product Directive 2014/40/EU of an article detailing a process for notification of ‘novel tobacco products’ (Article 19) is a significant change in the revised directive and did not exist in 2001/37/EC. This is significant because the judgement in C-210/03 relied heavily on arguing that the non-discrimination principle did not apply because snus was a new product in the markets where it was to be banned (see paras 5, 7, 8, 37, 49, 51, 55, 65, 67 and finally the conclusion at para 71 of the judgement).
The position is now that either:
- snus is discriminated against because, absurdly, it is treated differently to smokeless tobacco products that are chewed rather than sucked.
- or snus is discriminated against because it is treated differently to other novel tobacco products.
There is no escape from this – the court’s ‘novel product’ rationale from the 2003 case based is gone. Of course, snus isn’t a novel product – it is widely known and well-understood and should be treated as any other smokeless tobacco product.
7. The obvious disproportionality of a ban compared to other smokeless tobacco and cigarettes
Some of the reasoning in case C-210/03 looks ridiculous now – and relies on several false premises. See, for example, the exaggeration of risk at para 65:
“it had been proved that smokeless tobacco products were a major risk factor as regards cancer”
That is simply incorrect [see Lee PN, Epidemiological evidence relating snus to health–an updated review based on recent publications, Harm Reduct J. 2013; 10: 36. There is at worst a controversy about some kinds of cancer (e.g. pancreatic), but nothing remotely close to the cancer burden of smoking]
See also the unjustified rejection of the harm reduction concept at para 51:
“while part of the scientific community accepted that tobacco products for oral use could be used as substitute products for cigarettes, another part challenged the correctness of such a position”
That other part of the scientific community is plain wrong, and they should be accepting responsibility for the death and disease their unscientific opinions have caused, for example in Finland, where the declining trend in smoking slowed following the snus ban. s
8. The weakness of the Commission justification for the ban
The Commission’s case for banning snus is made in the Impact Assessment (pages: 50-52 and 61-76). It is easily and comprehensively dismantled in the following document: Proposed revisions to the Tobacco Products Directive: a critique of the scientific reasoning supporting the proposed measures relating to oral tobacco by Lars Ramström and me.
“We show that the scientific reasoning in the impact assessment has pervasive errors of fact and interpretation, selective use of evidence, important omissions, and poor conceptual framing. Legislation based on flawed scientific foundations will harm the health of Europeans, impede the development of the internal market and open the directive to legal challenge”.
We sent the Commission, Council and Parliament this document in time for it to be considered before the ban was finalised – see correspondence here – so they cannot plead ignorance. There was no response.
9. Formal consultation support for lifting the ban
The Commission consulted on plans for the new directive in 2010 and asked if the snus ban should remain; be lifted; or extended to all smokeless tobacco. Although the Commission claims support for the ban in its report on the consultation, the Public Consultation Statistics (page 5) show 83.15% of those responding to the question favoured lifting the snus ban.
But interestingly, the Governmental Representatives Response Statistics also show a majority (see page 25). This table (extracted below) has obvious totalling errors, but it looks like 217 of 342 (not 252 as stated) that expressed a view or 63.5% were in favour of lifting the ban on snus. Total governmental responses were 436.
10. The alleged criminality of former Commissioner Dalli and/or his associates
It is clear that persons close to EU Health Commissioner Dalli were actively soliciting a bribe from Swedish Match to lift the ban on snus. It is disputed whether Dalli resigned or was fired as a result – for our purposes it hardly matters. The stench around Dalli means we cannot be sure an objective approach was taken in drawing up the Commission proposal in 2012. See the OLAF report of the investigation into Dalli leaked to Malta Today, coverage in the New York Times of Dalli’s behaviour, and the excellent relentless investigative journalism of Daphne Caruana Galizia.
UK government Department of Health reaction
No doubt the UK government will feel obliged to defend this case. But why? The case for lifting the ban is extremely strong.
It would be much easier (and more honest) for the UK not to contest the Swedish Match action and to lift the ban. It would then need to defend itself in court against infraction proceedings brought by the Commission, which would be straightforward, given the strength of the case to lift the ban.
I’ll believe it when I see it.
Perhaps the UK could consider lifting the ban when it’s finally out.
Clive, if that fails, will you still think Brexit is a terrible idea?
Brexit will remain a terrible idea whatever the outcome – mainly because there is much more at stake than snus. A long recession and disinvestment from the UK is not something I would wish to see self-inflicted.
But also because it is likely that UK will negotiate a Brexit option that provides for access to the single market. In doing so, we will have to agree to sign up to single market directives like the TPD but lose all say over their future development.
As I keep saying, the question was not “do I like or dislike the EU?” it was “should we leave or remain?”. The latter involves assessing the relative merits of remaining and leaving and working through trade-offs such as the incompatibility of single market access and control on the free movement of people. No-one, least of all the Leave leadership, can say what they mean by Brexit, so I don’t really know how people decided that leaving would be better.
Hi Clive
on the issue of Brexit I think we should have a 2nd referendum for the following reasons (sorry to go off the point!!!):
1.Government website crashed night before and those that could not log on and register as voters were likely to be ‘remain’ younger voters.
2.Any constitutional change should constitute a 2/3 majority as it does in most countries (& EU referendum rules?). Some top Constitutional lawyers believe this is enough to block the exit in the UK. Almost as many people voted to remain in the referendum: London (& greater north London), Brighton and Hove and West Oxford and Devon voted to remain. Obviously Scotland overwhelming voted to remain as did Northern Ireland. In addition, those below the age of 45 years voted to remain. For those below 25 years 73% voted to remain. In fact if more young people voted the results would have been the other way round but the difference would be more pronounced for ‘remain’.
3.Brexiteers’ lied (and those that wanted to remain!) and have no exit strategy – ‘information currency of democracy’ and informed votes were not cast. In fact, some of the statements were designed to deliberately mislead. In addition, all the ‘Brexiteers’ have resigned. Thus, not only is there no exit strategy but all those who believed in Brexit have resigned. Even Nigel Farage!
4.EU will make an example of us.
5.Extreme economic crisis – Brexit itself will cost billions irrespective of the final impact on the economy.
‘Bottle half full’ – Politics will change forever. For example, there could be a rise in the Liberal Democrats, one of the most underrated parties of all time!
“In doing so, we will have to agree to sign up to single market directives like the TPD but lose all say over their future development.”
Where is the evidence for this? Many countries have access to the single market. They do not have to abide by the TPD, although they have to comply with product regulation, restrictions on sales and tariffs, The US exports into the EU, for example, and AFIK does not have a Snus ban.
Side Note: The Snus ban, in the UK, came in as a result of media hysteria about Skol Bandits in 1990. This was before the single market was even created.
By ‘access to the single market’, I really mean participate in the single market- that is to be part of the free-trade area created by the EU and EEA. Any other country can sell into the single market countries, but not under same the terms of trade as single market participants. The most important case is financial services (“the City”), where participation in the single market means financial services companies in the UK can also operate freely in other EU states.
Thank you for the clarification. Norway are in EFTA/EEA and do not have a Snus ban although it has been proposed in the past. Now the TPD has been brought in the EU are Norway going to implement a Snus ban as a direct result or does Norway take a separate decision?
My understanding is that the TPD has not yet been incorporated into the EEA agreement and therefore Norway, at this time, uses its own initiatives. Some of these may be based on the TPD although as far as I can ascertain they do not include a Snus ban.
From what I gather and of interest to vapers is that Norway is proposing to Lift its current ban on e-cigarettes. (June 2016 – Proposed amendments to Norway’s Tobacco Control Act)
As I suggested before, far from having no say, Norway have a say at both global/EEA levels and can act autonomously.
The snus position in Norway is an anomaly arising from the terms of its abortive accession agreement (similar to Sweden’s). You can’t generalise about EEA / EFTA from snus experience or to other countries.
Yes, I understand what the question was and you’re perfectly right about that, but precisely, if the EU snus ban survives a perfectly well founded legal challenge, that puts into question the rule of law inside the EU, if their legal procedures are something of a facade.
The outcome of the e-cig challenge didn’t make the EU look very good for the same reason. So I was wondering whether you would still trust the EU if this challenge goes the same way.
As for the TPD, you’re probably right but I notice that Norway, Iceland or Switzerland didn’t have to sign up for it.
No, I don’t trust it.. But my starting point is the role that our government plays… We can hardly blame something amorphous like the EU if our own government, Sweden, Finland etc are happy to go along with a ban. They are the cause of the problem and the EU is just the meeting room where this is played out. The origin of the problem is the public health lobby, which governments are stupid enough to take seriously.
I tried writing to UK Secretary of State for Health, Jeremy Hunt, [letter] and didn’t even get a reply. The problem starts at home and then how we play our hand in Brussels – we can’t blame the EU for the UK taking a totally stupid position.
In these issues, the law depends on your interpretation of the science – so the rule of law depends on who you believe about science.
I think it highly likely that Dalli was sacked because he was seriously thinking about lifting the Snus ban. He figured he’d go out with a big score, as his term of office was coming to an end.
He was almost certainly prepared to take the initial €10 million fee asked by his team, and start to progress the ban reversal process. Unfortunately Swedish Match had a sudden attack of righteousness – fatal for large corporates – and squealed. As a result, Dalli was fired and the Snus ban stayed on the books.
It’s more than likely Swedish Match’s new approach will cost more than €10m, though perhaps not the likely €20m they would have had to stump up in total to comply with a compromise deal to match the Dalli team’s initial figure of €60m.
In the end, SM thought the price was too high, dobbed Dalli in, and lost a pretty much guaranteed end to the Snus ban (for which they could have defrayed the costs with other producers, as is the norm in large industries buying laws).
Dalli got the chop and all his bent laws stayed on the books. A big win for the giant multinationals – quel surprise…
I’ll be amazed if the ECJ rules for justice and SM, against all the states / pharma / cigarette trade money, though – they just demonstrated with the ecig decision they’re about as bent as you can get without disappearing up your own exhaust.
Oh what fun :)
…aaand of course I was right.
Brexit was handled incorrectly. The Prime Minister should not have been involved in the Propaganda. As the head of the Government, he should have simply observed the action. Then, whatever the vote, he could have continued doing “the wishes” of the people. The GOVERNMENT should have had plans on exiting the EU. Leavers were from all political parties. Leavers are not the government. The fact that the government had no plan or even the vaguest expectation people would vote Leave, shows how out of touch with the people they have been.
People who want a second referendum must live in Remain areas – out of touch with those areas, like mine, who were almost exclusively for Leave.
Quote – “Public support for lifting the ban” is one of Clive’s points that the Legal challenge might be successful. I doubt that. The same arrogance about “Public Support” for Leaving the EU will be in place by the experts and leaders of Anti Snus to trivialise/diminish the importance of the (favourable) Public Consultation. They might just brush it off. Like Remainers do of the Leavers -as the opinions of the ignorant masses, that can be dismissed by the self righteous as foolish.
Forgot to tick the notify box! Damn.
As regards point 9 in this excellent exposé there is also the not insignificant matter of the “Government” contributions, 472 in all. 62,5% were in favor of lifting the ban and 17,5% were neutral on the issue, thus an 80% total seeing the merits, or some merits, of lifting the snus ban. Predictably this document was available to the public from DG-SANCO (old name for DG Health) but in a format that was locked for copy and data mining. It was necessary to go through each line separately to arrive at the numbers above and took about 2 full working days on a very very big screen, with pencil and notepad. SANCO of course did not release any of this data to the public, and instead asked each country for an “official” country position paper on lifting the snus ban. This was done post consultation and then generated the the desired results: An almost universal move to keep the ban. I find it hard to believe this action had been taken by SANCO/Dalli had the original “Government” replies in the actual consultation been satisfactory on the snus issue. But then again I might be wrong :)
Thanks for pointing this out – I’ve updated the posting. But I think the numbers are slightly different….
436 ‘governmental’ responses out of 85,513
342 of the 436 responded to the question on banning snus
217 of the 342 supported lifting the ban = 63.5% of those responding to this question.
Sadly, the table in the report seems to have totalling errors, which makes the data confusing and wrong.
As to your point 7 comment about the controversy concerning pancreatic cancer, Swedish males have the lowest rate in the EU:
http://eco.iarc.fr/eucan/Cancer.aspx?Cancer=15
As has happened with other scares on snus (and vaping, NRT and any other alternative to cigarettes) the story gets out, often based on a poorly conducted study, and the proponents of an abstinence-only approach keep hyping the supposed risk long after it has been shown to be factually incorrect.
Alternatively, those claiming that snus causes pancreatic cancer need to develop an alternative hypothesis to explain why Swedish males, with their very high incidence of snus use, have such a low incidence of the disease. Maybe there is something about having the second best ice hockey players in the world that is somehow protective?
Dear David and Clive,
Thanks for correcting me on the numbers, the ones not answering specifically, reasonably had no views one way or the other? BTW regarding pancreas, according to another source, NordCan (also at IARC http://www-dep.iarc.fr/NORDCAN/SW/frame.asp):
W-rates (age standardized per 100k) for pancreatic with sex separation in Scandinavia is:
Sweden: M 5,9 F 5,1
Norway: M 7,7 F 6,5
Finland: M 9,7 F 7,2
Denmark M 9,1 F 7,4
Iceland M 6,1 F 5,5
The two countries with historically the largest proportion male smokeless users, Sweden and Iceland, have the lowest sex difference in pancreatic cancer in the Nordics, followed by Norway that is 13 years into a snus shift.
Non snus Scandinavian countries (Iceland hides stats on neftobakk, has traditionally low smoking, and is included in snus countries) have MALE pancreatic cancer W-rates between 18%-64% above the snus countries.
Non snus Scandinavian countries (Iceland hides stats on neftobakk and are included in snus countries) have FEMALE pancreatic cancer W-rates between 11%-45% above the snus countries.
Using Sweden as lead it seems that in a very gender equal country with high male prevalence of modern SLT use, shows the use to be unimportant in regards to levels of pancreatic cancer, other factors likely to dominate instead
Just a thought.
Thanks for that info Atakan.
I second this. That is good and thorough work.
I do not want to piss on the party.
One reason it will fail: UK supreme court decided you can only contest UK-law after UK-law was written. UK-law however is still a mandatory implementation of a EU-directive so they referred it to EU-court. By the time it gets there (14-20 months) UK will no longer be a memberstate, so the UK will no longer have the obligation to keep all those EU-directives into their UK-law. The EU-court will no longer have jurisprudence over UK-implementations of EU-directives. They can not other then dismiss the SM-NNA case because the UK-referral lost its grounds by changed circumstances. Case is closed the minute art. 50 is invoked.
Both SM and NNA now share the huge responsibility for such thing not to happen; they both have their legal advisors who are paid to foresee such problems and to provide the right answers to counter this. SM challenged to protect their business so if it fails on this they only have themselves to blame. NNA however challenged to protect and ‘save lives’, if they fail on a foreseeable and avoidable technicality their will bare an enormous responsibility to society.
Wrong! 24 months from triggering – so 24 months from end March 2017. Timescale predicted to be 12-18 months from Jan 2017. At which point UK is still a member state, and the decision applies to whole EU.
Or would you rather that we just didn’t try at all?
Now you’re facing the EU-commission in court, and IMO they WILL use Brexit as an excuse to get the case dismissed. You can agree to disagree, Frankly I no longer care…
Hey captain, iceberg ahead!
And if the captain decides detouring that iceberg would disturb the orchestra playing at the party deck, I’ll better move to another ship…
SM decided to bring the case in the UK. NNA decided to support the case. Not NNA’s choice to bring it in the UK, but to simply sit by and do nothing to support is, frankly, a ludicrous course to adopt. Whether it succeeds is a matter for the court, and past performance, although no real guide to the future, suggests it will be a rocky road. But I ask again, would you prefer the NNA did nothing? What, if anything, would YOU do?
Moreover, if the case DOES succeed, what then?
So far, all I see from you is criticism and pessimism, absent a counterfactual and constructive notion of what SHOULD be happening. That’s about as helpful as formulating a chocolate teapot.
Disclaimer: This is posted on my own behalf and should not be taken as the stance or opinion of any society or organisation of which I may be part.
I’m not sure I understand the value of being negative about this wholly positive development…
But some facts might help.
The Totally Wicked case was referred to the English High Court to Court of Justice of the EU
06/10/2016 – Date of referral from High Court
04/05/2016 – Date of decision by CJEU
That makes 576 days or two days short of 19 months.
So turning to the snus case
26/01/2017 – Date of referral from High Court in SM/NNA case
24/08/2017 – Date it would complete if on same timetable as TW
31/03/2019 – Earliest date UK will leave EU
That gives 794 days or 26 months for the CJEU to reach a decision – 7 months longer than the TW case.
It is also possible that UK will strike an interim arrangement with the EU that involves continued temporary participation in the single market, or that the UK will ultimately remain a member of the Single Market or the EU. It is also possible that UK parliament will delay the initiation of Article 50 until the logical time to do it, which is after the French and German elections are settled on 23 April 2017 and 24 September 2017 respectively. Then it will be clear who the European counterparty to the Brexit negotiation actually is.
Having said that, it is possible that the CJEU or the EC will act politically and try to use Brexit to run down the clock on the case. But that is not a reason not to try or to sneer at the efforts of others to make progress in reversing the most stupid piece of legislation ever made.
It is equally possible that the CJEU, having been asked to decide on this and having expended judicial resources on it will wish to clarify the law and applicability of the earlier case in new circumstances and expedite the case to ensure that it does reach a decision. I argue above the circumstances today are very different.