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Atakan Befrits | 16 February 2016

Important update: Swedish Court rules that vaping products are not medicines products.

The Swedish government proposes new tobacco legislation, which includes a number of very widely recognized and important proposals to reduce smoking. The government deserves praise for work on this issue. However there are two proposals that will have a negative impact on tobacco harm reduction in Sweden – the first is to raise the warning levels on snus, and the second is a possible de facto ban on nicotine e-cigarettes and fluids, reached outside the scope of the TPD.

The proposal on “snus” is to not invoke the unique derogation for this harm reduced product that is only allowed for sale in Sweden, and instead opt to harmonize the warning with other, more dangerous, smokeless products that are freely sold in the EU. Many of these products are acknowledged to have very serious health consequences whereas the Swedish snus product has not been shown to have any serious adverse health effects, despite well over 100 years of monitored use. This will prevent possible use in state funded smoke cessation initiatives, and reduce consumer confidence in its use instead of smoking. It will also send a negative message to other countries. (Page 39 of the bill)

The proposal on vaping products leaves the Supreme Administrative Court in Sweden free to judge on a currently active case and determine whether or not the Medical Products Agency in Sweden, who claim that it shall have the right to classify nicotine containing e-cigarette products as pharmaceutical products is right or not. Given the expected outcome of the case, implementation of TPD Article 20 will be moot. As a fall back position the bill proposes implementation of the full TPD Article 20, should the court rule against the Medical Products Agency. The prohibitive costs of the regulatory process to register e-cigarette products in a small market like Sweden would result in a de facto ban through no availability of the product class on the market for the foreseeable future. This “small market effect” is further compounded by the massive use of “snus” by Swedish men as a THR product. Given extreme marketing restrictions minimizing switching, almost half the market opportunity (for males) is already taken by snus. Given the legal framework in Sweden and the expressed safety concerns, passing the buck to the MPA seems the most likely option for the court, and is also in line with the express wishes of the MPA. That the result will be a de facto ban on e-cigarettes does not seem to be a valid factor, or maybe it is precisely the desired outcome (page 44 of the bill)

Health Minister Gabriel Wikström, on SVT (Public Service TV) on February 8th 2016, took a public stance to support the Tobacco Endgame by 2025 initiative. This goal is in principle of course commendable, especially where focused on smoking. The Minister used commendable terminology in the interview - he refrained from using the word tobacco and instead focused on the biggest avoidable health threat of all, smoking. One must assume and hope that this was a conscious wording and communication from the Government.

In light of this, it is important that the Government does not proceed with its intentions regarding snus and e-cigarettes.

On best estimates, the goal for a smoke-free Sweden in 2025 will not be met, and even if it were met, some 500,000 Swedes would still be smoking daily. They deserve the right to accurate information on, and access to, methods and products that can reduce their risk of dying prematurely.

There are two important things that the government needs to do to ensure that Swedes have access to alternative, low risk, nicotine delivery products.

First: snus should be governed entirely as a Swedish national concern, therefore, the warnings on snus should not be harmonized with tenfold more dangerous products allowed in the EU.

Through the derogation for snus in the accession treaty to the EU, the Swedish special legislation applies also to warnings and all other issues related to snus. All decisions regarding snus should in all respects be an entirely Swedish affair, based on globally recognized, best available science in the field, and tailored to best suit Swedish conditions. The current proposal to raise the warning on snus should therefore be removed in its entirety.

This together with other snus issues are to be addressed in a final report by March 1. This report has to be carefully analysed and evaluated in preparation for national legislation specific to snus. This cannot realistically be carried out satisfactorily for any legislation before the 20th May 2016 deadline.

Swedish snus is subject to a total ban in the EU, outside Sweden. That Sweden would also be prepared to accept a warning that is suitable only for more dangerous products is a misunderstanding of Swedish obligations that should be immediately corrected in the proposed bill.

The proposed elevated warning on snus in the proposed bill, should therefore be stricken in its entirety.

In the Framework Convention on Tobacco Control, the definition of tobacco control includes explicit “harm reduction” as a valid strategy with the same value as strategies to reduce the demand for and supply of tobacco. Snus undoubtedly fills all the objective conditions in the definition, as a harm reduction product. Therefore it is only a matter of time before the snus issue internationally becomes subject to legal proceedings to decide whether snus bans and snus misinformation constitute violations of the FCTC, and also constitute violations of United Nations International Covenant of Economic, Social and Cultural rights, Article 12 on the right to highest attainable standard of health.

Second, Sweden should not leave it open to the Supreme Administrative Court to approve the Medical Products Agency (MPA) as a control body for e-cigarettes. E-cigarettes should be subject to consumer regulations based on best scientific evidence

Sweden is a small country and has a very limited market. The Swedish market is furthermore unusual in that the tobacco market already consists of 49% snus. In the Swedish market much of the incentive to register e-cigarettes as pharmaceutical products is missing from an overall nicotine market. Thus it is likely that a pharmaceutical product classification of e-cigarettes will have the perverse effect that no such products will be on sale.

A pharmaceutical product classification of e-cigarettes in Sweden will have the effect of a de facto complete ban, despite the fact that on paper it may seem a more permissive strategy than the EU TPD requirements. E-cigarette products differ from snus in that they are used to the same extent by men and women. Snus meanwhile is mainly used by men who comprise 85%, of the 300,000 Swedes using this product explicitly to no longer smoke. A pharmaceutical product classification will have a very skewed and negative impact especially on women’s smoking cessation, the group in Sweden who smoke the most.

England, France, Belgium and Germany are under huge pressure to rethink their approaches to e-cigarettes and the way they are treated in the Tobacco Product Directive’s Article 20, in terms of country-specific legislation. Sweden should therefore also not be in a hurry, or commit itself completely, to either Article 20 of the Directive or by entrusting the regulation of e-cigarettes to the MPA. If Sweden is compelled to incorporate Article 20 into Swedish legislation, a separate process should be started to do this in a way that is optimal for public health in Sweden, and that strikes the best balance of options and regulations for smokers, non-smokers and young people.

Public health in Sweden is more important than hurrying to meet EU deadlines.


 

Update:, February 17

A big win on February 17th for tobacco harm reduction in Sweden. The Swedish Supreme Administrative Court cares more about Public Health than the Government, Public Health Agencies, and tax funded anti-nicotine lobby organizations do together. The court has ruled that vaping products are not advertised as, nor proven effective, for the purpose of smoking cessation, and therefore are not applicable for medicinal regulation. Hopefully this ruling is a result of a pragmatic view by the court.

The court, on February 17th issued a landmark ruling, which prevents the Swedish Medical Products Agency from asserting full control over (and de facto banning) e-cigarette products in Sweden. The Tobacco Products Directive is most certainly a piece of legislative and regulatory catastrophe, but is an infinitely preferable alternative to de facto banning vaping through a legal manoeuvre that does not adequately take currently best available science in to account.

Left on the table as usual, is still the question of snus. Swedish >98% harm reduced spitless oral tobacco, is banned in the entire EU outside Sweden. The Swedish Members of Parliament will hopefully come to their senses and block the initiative to harmonize snus warnings with other more dangerous products which are free for sale in the EU. The snus ban in the EU may yet hopefully get a more scientific evaluation as a result of the shifting sentiments and evaluations of e-cigarettes in the EU.

A formal counter motion on snus was filed by the second largest party in the Swedish Parliament, also on February 17th. In the motion it is argued that since snus does have a derogation in the accession treaty for Sweden to the EU, all issues snus related should be an entirely domestic affair for the Kingdom of Sweden.

The fact remains, that snus still prevents a lot more illness and premature death per capita in Sweden, than do e-cigarettes in the EU, so it is not an unimportant issue.

Let us face the facts and the science and work toward a future with a wide range of vastly safer, attractive, affordable and enjoyable consumer nicotine products. Not only in the west, but globally.

Atakan Befrits, Sweden