Q. What do e-cigarettes and garlic capsules have in common?
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
1. Netherlands
2. Cologne, Germany
3. Sachsen-Anhalt, Germany
4. Estonia
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.
Another good post, Clive.
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and
http://www.ukvapers.org
http://www.planetofthevapes.co.uk as well for more information and a friendly forum :)
Thank you for this analysis, Clive. Excellent research and interpretation. It is very useful to see the ECJ’s approach is the same as national supreme courts, in that there is no legal justification for medical classification of consumer products such as e-cigarettes, garlic, coffee and so on.
I think it is quite likely that the TPD will pass, and therefore the trade will need to fund a challenge in Strasbourg. Indeed this process will need to repeated globally wherever the pharmaceutical industry succeed in purchasing bans. Eventually we will triumph (except no doubt in dictatorships), although this will probably be a long war.
There are several implicit dangers as a result of the huge funds pharma has available to buy decisions. To date, all court judgements have been universal; as an example the USA reversal of their ban involved all 13 judges ruling the ban illegal. The same applied, I believe, in Holland and both German challenges; the courts have shown themselves remarkably independent. Perhaps the first judge deciding for what appears to be a universally illegal action will demonstrate that impartiality cannot always be guaranteed.
Another is tobacco classification, since this offers multiple ways to remove e-cigarettes as an effective substitute for tobacco cigarettes. This might be a more difficult challenge to fight, and will probably be the chosen attack vector when it turns out that pharma funds can’t buy the law as cheaply as EU committee members, government staff, and medics.
Chris Price
Secretary
ECCA UK
Chris – thanks for this… There are all manner of ways to shunt e-cigs into the sidings of irrelevance … The deeper question is why do people want to do this and why are hey so cavalier with people’s health and rights..,?
Thank you from all the members at Planet Of The Vapes for all that you do Clive, it is appreciated by so many people. Excellent read!
I am not a lawyer, but I did stay at a Holiday Inn Express once.
Heroin addiction is not a disease. Therefore, methadone is not a medicine.
Methadone simply replaces one addiction for another, and the user is then weaned off the methadone with fewer side-effects.
Your arguments are well-thought out and logical, and therefore inadmissible in EU regulatory politics.
Mark … We’ll see… When the arguments are about legality, some of them have to imagine themselves on the stand giving evidence… and they know the court doesn’t tolerate lazy politically expedient b****cks.
There is some great discussion on this issue at http://www.reddit.com/r/electronic_cigarette/ . Here, find user testimonials, and also discussion about the FDA’s current attempt to classify electronic cigarettes as a tobacco product. To the layman (or woman) this move on the FDA’s part seems ludicrous, but understandable when you realize that the FDA is operating as an arm of Big Pharma. This statement from Mr. Bates fits into the scenario in the US as well as that in the EU: “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.”
This was an issue brought up when considering whether e-cig companies should be allowed to make therapeutic claims. I think the general consensus in the end was that they simply didn’t need to, as they weren’t selling therapuetic products. Claiming that e-cigs reduce tobacco smoking is not a therapeutic claim becuase smoking itself is not a disease. It is a behaviour.
Quote from section 5 of this blog ; http://vapersnightlynews.blogspot.com.au/2013/01/the-anti-tobacco-activists-foundation.html
“There is really no need for electronic cigarettes to be proved as smoking cessation product. Smoking cessation is actually a product of electronic cigarette usage. Only in the false conception that tobacco smoking is a disease, does the electronic cigarette’s smoking cessation property become a therapeutic device, and therefore subject to regulations imposed on therapeutics”
Prof Siegel also wrote about this in depth here ;
“Smoking itself is not a disease, but a behavior. Just as eating unhealthy food is not a disease, but a behavior. Or as not exercising is not a disease, but a behavior. Or as drinking alcohol is not a disease, but a behavior.”
“electronic cigarette companies should be allowed to truthfully inform consumers that their products may be useful for smoking cessation, as long as these claims are made within the general framework of marketing electronic cigarettes as an alternative to tobacco cigarettes. Such claims are not therapeutic claims as defined by section 201g of the FDCA.”
Finally “Someone to be heard” admits the garbage “ecigs are medicine”.
Hint: Have a look at “EuGH C-27/08”
It shows that a pharmacological effect is interpreted as a therapeutic effect (a toxic effect is not a (negative) pharmacological effect within the meaning of Article 1 No.2. Directive 2001/83/EC interpreted.
and “EuGH C-140/07”
It shows that the Authority shall provide scientific evidence of the pharmacological effect, if it is to classify a product as a drug.
So:
1. Nothing can be healed with nicotine -> No medicine!
2. No manufacturer claims a healing effect -> No medicine!
3. A toxic effect (nicotine) makes -> No medicine!
4. No scientific proof of a “believed healing effect” -> No medicine!
Regards
Jens Mellin
Another one:
Directive (2001/83/EC) – Definition of “What is a medical product”:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
To clarify the definition of a medical product:
(a) means: Presentation medicine – Someone (a manufacturer) claims that a product “can heal or treat” a disease.
(b) means: Functional medicine – A product that “can heal or treat” a disease.
To clarify (a) in a simple way:
1. Take a flower and dye it red.
2. Put this red flower in a nice box.
3. Put at label with “This will ease your headache” at the box. (That’s the “presentation part”!)
4. Prove that this product will harm no one.
5. Tadaaa: You’ve made a Presentation medicine, in a few month.
To clarify (b) in a simple way:
1. Invent a substance or substance compilation, that will effect a disease.
2. Apply for an medicine-admission.
3. Perform multiple longterm clinical studies.
4. Prove that this product will heal something and few possible harm.
5. Tadaaaa: You’ve got a functional medicine, at last.
After that is cleared, let us ask ourselves ONE question:
What kind of medical products are NRTs like Nicotinegum, Nicotinepatch, Nicotineinhalator, etc.?
Do you see daylight? :D
NRTs are PRESENTATION MEDICINE!!!
Here are my final questions:
HOW is it possible that the EU-Commission define ecigs on a certain dose of nicotine as a “medicinal product by function”, even though ALL available NRT in the EU are only “presentation drug”?
Why is this contrary to the prevailing EU jurisprudence which “defines a drug”, even though the e-cigarette is no presentation (no one claims that the ecig “could heal something”) yet functional medicine (there is nothing to heal!) and the ECJ has already held that a pharmacological effect is interpreted as a therapeutic effect (a toxic effect is not a (negative) pharmacological effect.
Regards
Jens Mellin
“Those in charge” know exactly what they are doing.
“They” understand that e-cigarettes are no drug according to Directive 2001/83/EC.
Question: “What do you do when a new rule is unlawful?”
Answer: “Simply, change the law!
See Amendment 44 on page 27 of the DRAFT OPINION of the Committee on the Internal Market and Consumer Protection:
“1. Nicotine-containing products may only
be placed on the market if they were
authorised pursuant to Directive
2001/83/EC”
http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fNONSGML%2bCOMPARL%2bPE-508.048%2b01%2bDOC%2bPDF%2bV0%2f%2fEN
2 or 4mg limit? No – ALL Nicotine-containing products!
“Those in charge” know exactly what they are doing.
“They” understand that e-cigarettes are no drug according to Directive 2001/83/EC.
Question: “What do you do when a new rule is unlawful?”
Answer: “Simply, change the law!
See Amendment 44 on page 27 of the DRAFT OPINION of the Committee on the Internal Market and Consumer Protection (dated 27.3.2013) :
“1. Nicotine-containing products may only
be placed on the market if they were
authorised pursuant to Directive
2001/83/EC”
http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fNONSGML%2bCOMPARL%2bPE-508.048%2b01%2bDOC%2bPDF%2bV0%2f%2fEN
2 or 4mg limit? No – ALL Nicotine-containing products!
Well I think the limit is a bit of a red herring anyway. You would need two regulatory systems. The main thing is to either stop medicines regulation applying or to get NCPs out of the tobacco directive altogether. One useful thing is a three year lead time. Plenty of time for supplier adjustment and legal action.
Wow, awesome blog, thanks for the article.