E-cigarettes could become 'medicines'

James Meikle

E-cigarettes could be available on the NHS by the end of the year with at least two companies – one a subsidiary of British American Tobacco – having already embarked on the process of obtaining licences from the medicines regulator.

The UK company Nicolites said its application was "well-advanced" while BAT's Nicoventures has also started the process, although decisions on whether their products are prescribed on the NHS will be made by local commissioning groups.

The status of "medicines" will give the companies commercial advantage and allow the e-cigarette makers to market their product internationally, including in sponsorship deals, a move that will be banned for competitors not in the same bracket.

The news came to light as ministers in England prepare to ban the sale of e-cigarettes to under 18s – Wales and Scotland are likely to follow suit.

The Advertising Standards Agency is also about to launch a consultation on new rules to cover e-cigarettes, used by 1.3 million people in Britain last year. It will start later this month, with the framework likely to be in place by autumn, nearly two years after the first TV adverts for such products.

The applications to the Medicines and Healthcare Regulatory Authority are a victory for the regulator's determination to persuade manufacturers and importers to apply voluntarily for a licence and meet specific rules including on the amount of nicotine provided. They are continuing the process even though the European parliament defeated UK attempts to make medicinal licensing compulsory for e-cigarettes last autumn,.

Existing anti-smoking therapies such as gums, patches, an inhaler, and a mouthspray already have medicine licences and have been endorsed by the National Institute for Health and Clinical Excellence, which advises on good practice and value for money. Nearly 1.4m prescriptions for them were issued in England in 2012, but licensed e-cigarettes would not need a separate Nice assessment.

Nikhil Nathwani, managing director of Nicolites, said the company was "well advanced in the product's licencing" and hoped to achieve marketing authorisation some time this year. It was working closely with the government, the regulator and Nice. "This will be continued even after marketing authorisation has been achieved", he said. Nicoventures has also made a licence application for a nicotine inhalation device to the MHRA.

A spokesman for BAT, which already has a standard e-cigarette brand, Vype, on sale in Britain, said the company would like to see "a regulatory approach that puts consumer safety and product quality first, while allowing the appropriate level of innovation, marketing and distribution freedoms to allow this important new product category to grow."

A spokesperson for Njoy, a big US cigarette company, which has also endorsed MHRA regulation, could not say whether an application was in progress, when contacted.

The readiness of big e-cigarette players to go down the voluntary route for the expensive process of medicines approval is in sharp contrast to the position of the UK trade body for e-cigarettes, Ecita, which has railed against the over-regulation it claims will be introduced EU-wide.

E-cigarettes classed only as consumer products from 2016 will have to carry health warnings that nicotine is highly addictive. The draft EU directive, which has still to complete its legislative process in the coming months also contains new curbs on tobacco – including health warnings covering nearly two thirds of cigarette packs. guardian