A new nicotine replacement device, similar to an e-cigarette, has become the first product of its kind to be licenced as a medicine in the UK.
Developed by a small health technology company in partnership with British American Tobacco (BAT), the nicotine inhaler device could be on shelves in high street chemists within months and could also be offered by GPs and stop smoking services.
The decision paves the way for the product to be given free or on prescription to NHS patients trying to quit smoking, meaning that NHS funds would be contributing to the profits of one of the world’s biggest tobacco companies.
However, anti-smoking campaigners have said that, while the link with Big Tobacco raised an “ethical dilemma”, the decision was an “important step” and called for other tobacco alternatives, including e-cigarettes, to seek medicines licences.
Regulators at the Medicines and Healthcare Regulatory Agency (MHRA) announced that the Voke Inhaler, manufactured by the UK firm Kind Consumer, had passed safety, quality and efficacy tests and could be sold as a medicine to aid smoking cessation.
Kind Consumer signed a deal with Nicoventures, a subsidiary of BAT, in 2010 to distribute and market the product worldwide.
The device will not be available for several months because a newer version, redesigned to be suitable for mass production, still needs to meet MHRA approval, but the decision marks a major milestone.
Moves to regulate e-cigarettes and similar products as medicines come amid increasing evidence of their effectiveness in helping people to quit smoking. Guaranteeing their safety and efficacy via the strict medicines licencing regime is viewed as the best way to guide smokers to the best products.
However, the tobacco industry has been heavily involved in the development of several products. The expensive regulatory process means that some small firms have turned to Big Tobacco for financial support. The tobacco industry, meanwhile, views e-cigarettes and similar devices as a potential growth area, and is determined to protect its profits even as smokers turn away from tobacco.
Deborah Arnott, chief executive of the charity Action on Smoking and Health (ASH) told The Independent that tobacco companies should be allowed to move their operations into nicotine replacement devices – including those licenced as medicines.
“There is an ethical dilemma and we’d much rather it wasn’t BAT that had the licence, but unfortunately when Kind Consumer were looking for investment, no-one else was interested,” she said. “Medicine regulation is really important to ensure that products are of an appropriate standard. If we want the tobacco industry to stop producing tobacco, and to get out of producing and selling products that kill people, then they have to be allowed to move into other areas.”
The Voke inhaler is different to an e-cigarette. It is a non-electronic device which uses a breath operated valve to deliver nicotine, rather than using heat or combustion like an e-cigarette. Nicotine alone, although highly addictive, is significantly less harmful than the cocktail of toxic chemicals ingested by smoking tobacco.
Public health experts are still divided over the relative risks and benefits of e-cigarettes and similar products. The World Health Organisation said last month that e-cigs should be banned from indoor use in public, because of concerns around the safety of the vapour – warnings which have been dismissed by some scientists. Unlike e-cigarettes, the Voke inhaler does not produce vapour.