April 25th, 2014
The European Parliament rejected Commission proposals under the Tobacco Products Directive (“TPD”) to regulate e cigarettes as medicinal products in October 2013, but what does this mean in practice for the regulation of e cigarettes across the 28 EU Member States?
At present e cigarettes are regulated in a variety of ways across the various Member States across nine members states (including the UK) there are no specific rules relating to e cigarettes only existing consumer product safety legislation currently applies. In another eleven Member States (including Germany and the Netherlands), e cigarettes are considered medicinal products which subjects the products to stricter regulation. At the extreme, currently e cigarettes are prohibited in Greece unless specifically approved by the Health Ministry.
Under the original Commission proposal for the TPD, rules applying to e cigarettes would have been harmonized and e cigarettes would have been treated as medicinal products resulting in stricter regulation and a more costly approval process across the entire EU. Approvals for medicinal products cost on average f200,000 to secure. Regulating e cigarettes as medicinal products would also have limited sales points to pharmacies. The European Parliament rejected this proposal on in October 2013 and has now reached a compromise with the Council which will see the majority of e cigarettes regulated as consumer products.
While this should help to clarify the current regulatory uncertainty, the debate is far from over.
Although the full text of the compromise is not yet publicly available it is understood that the compromise sets mandatory safety and quality requirements, for example on nicotine content, ingredients and devices, as well as refill mechanisms. The new rules also make health warnings and information leaflets obligatory and introduce notification requirements for manufacturers and importers of e cigarettes, stricter rules on advertising and monitoring on market developments.
In relation to refillable e cigarettes the compromise contains a safeguard clause which could result in refillable e cigarettes being banned in the EU in the future.
The new rules are due to enter into force in 2016 (subject to adoption of the TPD in the course of 2014) and as such it is important that all manufacturers, exporters and importers of these products familiarize themselves with these new rules and begin considering securing any approvals that are necessary to ensure a smooth transition and continued access to the EU market.
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The deal, which has not been finalised, could see all e cigarettes with over 20 milligrams of nicotine brought under new restrictions.
The European parliament is understood to be content with the use of refillable nicotine cartridges, but member states such as Britain and Germany are concerned that the cartridges can contain up to 10 milligrams of nicotine the equivalent of a carton of 200 cigarettes.
If refillable e cigarettes are prohibited in at least three member states, the commission would be able to extend the ban to all member states.
If the talks fail, e cigarettes would remain unregulated, providing a sigh of relief to an industry which could outperform the f700 billion cigarette market within ten years.
Proposals for all electronic cigarettes to be controlled by pharmaceutical legislation were rejected by MEPs.
Liberal Democrat MEP and health spokeswoman in the European parliament Rebecca Taylor said “Significant ground had been won in the rejection of Europe wide medicines licensing. But the decision to potentially ban refillable cartridges and devices in future would be a backward step.”
Euromonitor currently puts the value of the market at f2 billion, but a surge of investment from big tobacco firms like Philip Morris owner Altria, British American Tobacco and Imperial Tobacco show there is widespread belief that electronic smoking could offer a popular substitute to the real thing.
A study published in the Lancet this year showed shifting to e cigarettes makes smokers at least as likely to quit as using nicotine patches and other research projects also suggest a significantly higher success rate than more traditional nicotine replacement options, like gum.
There are concerns around the safety of the product, however. A study presented at the American Society of Cell Biology in New Orleans showed prolonged exposure to nicotine, either through normal smoking or by e cigarettes, may damage the heart.
