The EU is set to introduce a system whereby companies manufacturing e-cigarettes can either opt to sell their products under the official Medicines’ Regulations or they can be regulated in a similar way to tobacco products.
However, the pharmaceutical industry, including pharmaceutical giant GSK, would like to see the introduction of medicines’ licences being mandatory for e-cigarettes.
GSK said in a letter to the UK Health Minster that regulating e-cigarettes as medicines would “clearly set out that the recreational use of e-cigarettes to reinforce tobacco dependency is unacceptable from a public health viewpoint.”
The company added, “We also need to establish the application of marketing practices that mitigate the risk of non-tobacco nicotine-containing products becoming a gateway to tobacco products.”
It is already known the e-cigarettes contain nicotine, which is a highly addictive and dangerous drug.
Minister Reilly intends to regulate the e-cigarette market in Ireland. This will include banning their sale to Under 18s. However when asked by Irish Pharmacy News for a comment, the Department of Health was unable to give a time line for the commencement for the ban.
The UK has already put a ban in place for the sale of the products to the Under 18s. The UK’s Chief Medical Officer, Sally Davies said in a statement, “We do not yet know the harm that e-cigarettes can cause to adults, let alone to children but we do know they are not risk-free.”
In Ireland the current position is that if these products are not presented as medicinal products for smoking cessation or as medical devices with a therapeutic purpose, they do not fall under the medicinal products or medical devices legislation.
The battery-powered products contain a cartridge filled with nicotine that has been dissolved in propylene glycol or vegetable glycerol and water. As e-cigarettes do not contain tobacco, they are currently not regulated under Irish tobacco legislation.
Euromonitor estimates that the global market for e-cigarettes is more than $2billion or €1.4 billion.
Tony Geraghty, Production Director of Rossport Pharmaceuticals told The Irish Independent that he estimates that 50,000 smokers in Ireland have switched to using e-cigarettes since their introduction.
In order to harmonise the way EU Member States regulate e-cigarettes, the new Tobacco Products Directive that has been voted in by the European Commission will provide for their regulation. It is anticipated that the Directive will be adopted formally by Council later this year, following the vote in the European Parliament in February 2013. Member States will have two years to transpose the Directive.
It is thought that the Directive will set mandatory safety and quality requirements for e-cigarettes that will not fall under the definition of medicinal products.
The new Directive will make health warnings and information leaflets obligatory and introduce notification requirements for manufacturers and importers of e-cigarettes, impose stricter rules on advertising and the monitoring of market developments. The Directive will also enable Member States and the European Commission to react in the case of any identified health concerns related to these products.
The EU has also proposed that e-cigarettes be banned entirely if three or more member states ban their use in their own countries.
Reilly said, in answer to a parliamentary question in January on e cigarettes, ‘Tobacco Free Ireland’, Ireland’s Tobacco Control Policy states that the general consensus at European level is that there is a lack of research in relation to the long term health effects of e-cigarettes and a lack of sufficient evidence that they aid with smoking cessation. I have asked my Department to review the issue, in order to inform policy and regulation in this area.”
Joseph JohnstonTags: e-cigarettes