16th January 2013
To: Dr Tonio Borg
Commissioner for Health and Consumer Policy
Dear Dr Borg,
Re: Proposed revisions to the Tobacco Products Directive
I should like to offer my congratulations on your appointment to this most important office, and hope that you will use your position to insist on robust evidence and unimpeded, unbiased expert opinions when making significant policy decisions which will affect the health and well-being of every citizen of the European Union.
Turning these consumer products into medicinal products would require a significant loss in the performance of the products. They would be required to deliver controlled doses, which would make them more like the medicinal nicotine inhaler than like a tobacco cigarette. Millions of EU citizens want and need a safer alternative to the tobacco cigarettes they are smoking. Non-medicinal electronic cigarettes can provide this; medicinal electronic cigarettes cannot. These products are appealing to and working for millions of EU smokers; why would the Commission want to “slow the pace”?
It would be a wasted opportunity not to offer smokers an appealing alternative to their cigarettes. Of financial necessity, regulation as a medicine would effectively eliminate flavourings, since each one would have to be licensed individually. It would also stifle the development of new and better models of electronic cigarettes, which smokers desperately need.
It is quite incomprehensible – not only to me, but to a wide range of public health experts with no connection to the electronic cigarette industry at all (see Appendix 1) – that the Commission should seek to put such restrictions on a consumer product which is currently helping many millions of EU citizens stay away from tobacco smoking by switching to using electronic cigarettes instead.
Does the Commission plan to revise the definitions of a medicinal product, as set out in Directive 2001/83/EC? If so, what is the justification for doing so? If not, how can electronic cigarettes be reclassified as medicinal products?
It seems ironic in the extreme that the proposal itself cannot be “justified by overriding reasons of public interest” and is neither “necessary” nor “proportionate”. Rather the proposed revisions to the Tobacco Products Directive appear to be precisely “a means of arbitrary discrimination” and “a disguised restriction on trade between the Member States”.
The simultaneous inclusion and exclusion of electronic cigarette products, combined with the attempt to reclassify some electronic cigarettes (but not others) as medicinal products (despite the legal challenges to this), would result in the significant inhibition of the free trade of electronic cigarette products within the European Union. No justification has been provided for this within the proposal.
Electronic cigarette products not designed as medical treatments for smokers, and not making medicinal claims, cannot be deemed medicinal products, as demonstrated in the various court rulings. In reality, the ‘level playing field’ for the internal market would be inappropriately ‘skewed’ in favour of the Pharmaceutical and Tobacco Industries if non-pharmaceutical and non-medical products were to be reclassified as medicinal products, in order to protect their interests at the expense of the Electronic Cigarette Industry.
The impact assessment also states: “Today, there are two categories of products containing nicotine available on the market: NCP placed on the market without any prior control and NRT (Nicotine Replacement Therapies) which have been subject to a strict (and relatively costly) risk/benefit analysis and approved as medicinal products.”
There are several inconsistencies and errors in this statement, not least that it leaves out the most obvious, and most widely available third ‘category of product containing nicotine’, namely tobacco cigarettes. These have not been ‘subject to a strict (and relatively costly) risk/benefit analysis’, so where is the justification for applying such a burdensome regulatory framework to electronic cigarettes?
If the fact that a product contains nicotine is all that is necessary for it to qualify as a medicinal product, then where are the draft proposals from the Commission that tobacco products – all of which contain nicotine – should have to undergo the “strict (and relatively costly) risk/benefit analysis” and gain approval as medicinal products. Where, exactly, does the need for a ‘level playing field’ start and end?
As David Sweanor, Adjunct Professor of Law at the University of Ottawa pointed out recently: “…the massive and numerous lawsuits against cigarette companies are not a result simply of them being cigarette companies, but rather a result of a failure to live up to their duty to consumers.”
How much greater is the duty of public officials, with a specific remit for protecting public health, to the citizens whose lives they seek to shepherd? The reputation of the Commission is, indeed, at stake. We trust you will not wish to make policy which would have such a devastating negative effect on the citizens whose health protection is your specific responsibility.
Thank you for your time and consideration.
Yours sincerely,
Katherine Devlin
President
ECITA (EU) Ltd
(The full text of our letter, together with appendices and references is available from our website.)
At ECCA we fully support ECITA’s excellent reponse to the proposed EU Tobacco Directive.
I personally would be more explicit and describe it as a product of what might be described as murderous corruption within the EU Health Commission, and I make no apology for describing it in such graphic terms. We already know that committee members solicit bribes of millions of Euros from affected parties, and that their exposed hidden offshore bank accounts contain huge sums of money – so I feel no apology is necessary.
Simply look at the facts:
- Sweden reduced their smoking prevalence by 45%, with a concomitant fall in the smoking-related disease and death rate (the ‘Swedish Miracle’), due to free and unhindered access to Snus.
- If Sweden can achieve 45% then perhaps other countries could achieve at least a 10% reduction in smoking with the same approach. Some would say a better result is possible in some places.
- The vast mountain of scientific evidence available for Snus (the 30 years of epidemiology, the incredible national health statistics, the hundreds of clinical studies) all show there is no statistically-demonstrated difference in expected health outcomes for smokers who quit totally or who those who switch to Snus: Snus consumption cannot be shown to elevate risk for any disease. The risk for a Snus consumer is about the same as for a non-smoker. Lee & Hamlin’s giant-scale meta-analyses of Snus studies make this abundantly clear.
- Sweden now has the lowest smoking-related death rate of any developed country by a wide margin (about half the EU average).
- Sweden has the lowest male lung cancer and oral cancer rate in the EU (according to Prof Brad Rodu, the world’s leading authority on oral pathology and tobacco issues, smoking has a risk for oral cancer that is four times higher than the most dangerous of all chewing tobaccos; and the risk for Snus is unmeasurably low).
- Some experts have said that e-cigarettes will have a risk profile equal to or better than Snus, as only nicotine is being consumed and not a whole tobacco product.
- In the short timescale they have been available, about 6% of UK smokers have already switched to an ecig. At least 500,000 people use them in the UK.
- The banning of Snus in the UK kills about 10% (or more) of UK smokers who die annually, since they have no access to a safer product that is proven in Sweden to dramatically reduce the death and disease rate. This is about 10,000 a year.
- E-cigarettes have been shown to be far more popular with smokers than Snus. This indicates that a greater than 45% reduction in smoking will be achievable.
- In turn, this indicates that the EU Health Commission will soon start to kill even more than the current 10% of smoking deaths it is responsible for. The number will before long run into the hundreds of thousands.
Why on earth would public health officials try to ensure that smokers are forced to continue smoking? We might perhaps look at one of the most important industries to benefit from these decisions: the world’s largest criminal fraudsters and criminal corrupters, the pharmaceutical industry (officially and legally-speaking, that is. The arms industry might be the popular title holder, but pharma has paid by far the largest fines for criminal fraud and criminal corruption, as these are a principal mode of their business operation. Their individual fines run into the billions…). Pharma has a $100bn annual drugs trade to protect: the huge market for drug treatments for sick and dying smokers: chemotherapy drugs, COPD drugs, cardiac drugs, vascular drugs, and all the other channels boosted by the effects of smoking. This stands to take a tremendous hit when ecigs take over 60% of the smoking market, as I believe they will eventually.
Don’t agree? Snus reduced smoking by 55% among men, 45% across male/female, in Sweden. You don’t think that ecigs can better that? Pharma does, which is why they are fighting so desperately hard to preserve the status quo.