A. Neither are medicines
Would it actually be legal to classify e-cigarettes as medicines? A landmark legal case involving the classification of garlic capsules suggests the European Court of Justice would not accept this definition. Other recent legal cases in member states support that interpretation. Let’s look at whether e-cigarettes really are medicines…
The proposed revision to the European Union Tobacco Products Directive would classify almost all e-cigarettes as medicines, and subject them to onerous compliance burdens, high costs and numerous restrictions. I have written at length about the dangers of applying excessive regulation (see Medicines Regulation for e-cigarettes: when caution can kill) and tipping the balance in favour of smoking (see Reduce harm or protect the cigarette industry?)
The European Commission has previously challenged member states when they have over-zealously classified non-medicinal products as medicines. In the ‘garlic capsule’ case of 2007 (C-319/05 – 15 November 2007) the European Commission challenged the classification of these products as a medicine by the regulators in the Federal Republic of Germany, on the grounds that they are not medicines and that the regulatory burdens of medicines regulation created disproportionate obstacles to trade in the EU internal market. For e-cigarettes, the case drew highly relevant conclusions in paragraphs 59-71 of the judgement. Some highlights are reproduced here (with emphasis added):
61 Contrary to the definition of medicinal product by presentation, whose broad interpretation is intended to protect consumers from products which do not have the effectiveness they are entitled to expect, the definition of medicinal product by function is designed to cover products whose pharmacological properties have been scientifically observed and which are genuinely designed to make a medical diagnosis or to restore, correct or modify physiological functions.
64 In those circumstances, and in order to preserve the effectiveness of that criterion, it is not sufficient that product has properties beneficial to health in general, but it must strictly speaking have the function of treating or preventing disease.
71. … the definition of medicinal products in particular, cannot result in obstacles to the free movement of goods which are entirely disproportionate to the pursued aim of protecting health.
Interpretation: this judgement stresses the balance to be struck between the efficient operation of the internal market and the burdens of regulation. In pursuit of this balance, the ECJ has tightly constrained what can be lawfully classed as medicines. The judgement limits medicines to products that are ‘genuinely designed’ to ‘modify physiological functions’ strictly with the ‘function of treating or preventing disease’. I don’t see how that restrictive definition can apply to e-cigarettes.
Go deeper into this? A more detailed discussion on the the status of e-cigarettes as medicines is available in my briefing: Are e-cigarettes medicines? Contents as follows:
Introduction – characteristics of e-cigarettes
An expert view and user view
Formal definition of medicine in EU law
UK regulatory committee challenges medicines classification
Legal interpretations in the European Union member states
2. Cologne, Germany
3. Sachsen-Anhalt, Germany
Relevant European Court of Justice case law
1. Germany – the garlic case
2. Germany – the fermented red rice case
Legal principle in the European Union
The principle of proportionality
The principle of non-discrimination
International legal provisions
WTO – Technical Barriers to Trade
What is the right approach to take?
Appendix: The garlic case – extract from ECJ judgement paragraphs 59-71
I hope you find this interesting: if I was a Commission official, MEP, regulator, European Council official or minister, I would be troubled by this. It suggests the approach taken in the directive to classifying e-cigarettes is probably unlawful, disproportionate and discriminatory.
Summing up. I’m not an e-cigarette or nicotine user myself, so I have relied on the extensive base of user testimonies: for example on e-cigarettedirect.co.uk, liberty-flights, e-cigarette-forum.com [Other good ones? Let me know in the comments]. Several things leap out from these accounts: real passion, commitment and pride; life-changing benefits – not just health but smell, impact on others and inconvenience; often failed attempts to quit nicotine use altogether, often with NRT… But what is especially clear, is that these users do not regard themselves as ‘in treatment’ or consuming a medicine. It is very clearly an alternative to smoking and the appropriate comparator is cigarette smoking, not NRT.
I had a go at summarising my own position in response to an article in the New Scientist in February 2013: E-cigarettes may soon be sold as life saving medicine. My response was:
There is a liberal argument that goes like this: if people want to sell them, people want to buy them, they are much less risky than cigarettes and they comply with norms of consumer protection – like being safe, working as intended (ie not faulty), and as-described – then why is the medicines regulator involved, and why is it necessary to set a bar before they can be placed on the market? Nicotine is a widely-used legal recreational drug that in itself is almost harmless, so why obstruct a much less dangerous way to take it with huge regulatory burdens that do not apply to cigarettes?
E-cigarettes are not a medicine, and they are not used to quit smoking in the same way as NRT (ie complete withdrawal from nicotine, with NRT providing subliminal relief from craving). E-cigarettes are used to smoke (‘vape’) in a different way, to obtain a satisfying nicotine ‘hit’ without many of the extreme disadvantages of tobacco smoke, but with some of the same ritual. The people using them do not define themselves as in treatment, and those selling them do not define themselves as health care providers. The appropriate comparator is a cigarette, not NRT smoking cessation products.
The health experts and campaigners should beware what they wish for. They could end up piling on compliance burdens, costs and disproportionate restrictions on e-cigarettes that do not apply to cigarettes – killing off the innovative suppliers. They may end up throttling an incredibly important ‘insurgent’ industry with the potential over time to transform the cigarette market. According to the WHO, one billion deaths are likely from tobacco in the 21st Century. Public health experts need to get used to the idea that changing markets for nicotine to much less dangerous products could dramatically reduce this awful toll.
Medicines regulation does have a place when therapeutic claims are made and perhaps to support health care professionals in recommending novel nicotine products to smokers. The right approach is to make medicines regulation an ‘opt in’ for those vendors who want to make health claims or who think the advantages in terms of consumer confidence, access to health care markets and assurance for retailers is worth it. Otherwise, standard consumer protection legislation has all the necessary tools to ensure e-cigarettes are safe, fit for purpose and as-described, without asphyxiating them with red tape.