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.
ECITA (EU) Ltd
(The full text of our letter, together with appendices and references is available from our website.)