E-cigarettes escape EU-wide regulation as medicines
This article was originally published in SRA
The European Parliament has voted through the draft revised Tobacco Products Directive but stopped short of backing moves to regulate e-cigarettes as medicinal products1. The matter is not over yet, though, as parliament's rapporteur for the legislation, MEP Linda McAvan, now has to enter negotiations with member state ministers on the final form of the directive, and some countries are known still to favour applying the medicines regulations to e-cigarettes.
Law firm Bristows described the vote as “the culmination of one of the most heavily scrutinised and widely publicised legislative battles witnessed in this parliamentary term”2.
The existing TPD is being revised and updated to address issues such as labelling and packaging of tobacco products, flavourings used in cigarettes, and internet sales of tobacco products. The overall aims are to discourage young people from taking up smoking, reduce the disease burden resulting from use of tobacco products, and lay down clearer rules for tobacco manufacturers.
Other than the overall healthcare implications of reducing tobacco consumption, one item of interest to the pharmaceutical sector was the proposal to apply the medicines legislation to e-cigarettes with a nicotine content over a specified threshold.
Proponents of the move said this would lay down high quality standards for e-cigarettes, help protect consumers from possible harm, and ensure that manufacturers wanting to make health claims for their products had a marketing authorization. They also noted that other nicotine-containing smoking cessation aids, such as gum, patches and inhalators, are already regulated as medicines.
Opponents claimed regulation as medicines would restrict the availability of e-cigarettes, push up their prices, and drive "vapers", ie users of the products, back to smoking tobacco cigarettes. They pointed out that e-cigarettes are much less harmful than smoking, and suggested that smaller e-cigarette companies could be driven out of business as the big tobacco companies moved into the newly regulated e-cigarette sector.
Negotiations next
Ms McAvan will now enter into negotiations with EU member state ministers over the final form of the directive. The MEP told a press conference immediately after the vote that she hoped to do this before the end of the year.
While parliament's vote suggests that plans to regulate e-cigarettes as medicines are dead in the water, things are not that clear cut. Some countries already treat them as medicines, for example, and the UK's Medicines and Healthcare Products Regulatory Agency has already conducted an extensive public consultation on its own plans for regulating the products3,4. The MHRA had hoped to begin licensing products before the directive came into force, going so far as to invite e-cigarette companies to apply for a medicines licence on a voluntary basis2,3.
A spokesman for the agency told Scrip Regulatory Affairs that the UK government's position at present was that the public health priority of reducing the harms of smoking could be "best achieved by the regulation of nicotine containing products (NCPs), including electronic cigarettes, under the medicines framework," and that it "supports the [European] Commission's Tobacco Products Directive."
Maria Isabel Manley, partner and head of the regulatory department at Bristows, commented before the vote that the rejection by parliament of the proposal would likely create “a level of disharmony” throughout Europe. Individual member states enforcing stricter regulation would “likely lead to a disjointed patchwork of regulation throughout Europe which would jeopardise the principle of free movement of good throughout the EU”, Ms Manley said.
Whatever happens ultimately, e-cigarettes will not escape totally unscathed, as they will be treated in a similar way to tobacco products. Among other things this will probably mean declaring their ingredients (as proposed for tobacco in the directive), putting health warnings on packs, and a ban on advertising, said a spokesman for the parliament. Moreover if they make any curative or preventive claims, they will be subject to the medicines regulations.
References
1. EP press release, 8 October 2013, www.europarl.europa.eu/news/en/news-room/content/20131004IPR21539/html/Tobacco-larger-warnings-flavours-banned-e-cigarettes-regulated
2. Bristows statement via email, 8 October 2013
3. UK to regulate all nicotine-containing products as drugs; will press for EU-wide consensus, Scrip Regulatory Affairs, 17 June 2013
4. E-cigarettes: a victory for pharma?, Scrip Regulatory Affairs, 19 June 2013