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Medicines regulation

Flexible approach to e-cigarette regulation needed

A flexible approach to regulation of electronic cigarettes is needed to avoid products that help people to quit smoking being taken off the market, a health psychologist has told the All-Party Pharmacy Group (APPG).

Robert West, of University College London, was speaking at an APPG meeting in Westminster last week (10 June 2014), where a panel discussed whether e-cigarettes are a “gateway to addiction or cessation”.

West said that current evidence suggests only 0.2% of never-smokers use e-cigarettes and that the devices are 20 times safer than tobacco. He told the APPG there is good evidence that the most successful devices at helping people to quit are the second-generation e-cigarettes rather than the first-generation products, many of which are made by tobacco companies.

First-generation “cig-a-like” products are usually the same size and shape as a cigarette and contain a set amount of liquid nicotine within a sealed cartridge. Second-generation products can be refilled with liquid nicotine and are generally much larger than a cigarette.

Rules laid out in the EU’s Tobacco Products Directive (TPD), due to come into force in May 2016, could see many of the second-generation products taken off the market. The UK Department of Health (DH) is currently looking at how to transpose the directive into law, but all e-cigarettes will either have to be licensed as medicines or they will have to comply with the rules of the TPD.



West called on the UK Government to design a regulatory model that would not limit the choice and appeal of e-cigarettes to smokers who want to quit. If we think of e-cigarettes as medicines we will get regulation all wrong, he said, warning that it will cost at least £1m and take upwards of 18 months to license an e-cigarette as a medicine. “Can we have a process that takes six months and costs £50,000?” he asked.

Jeremy Mean, deputy director, tobacco control and responsibility deal, DH, said that West’s approach is feasible and that medicines regulation in the UK is flexible. “The evolution from cig-a-likes to second generation products can fit within medicines regulation,” he said, adding that he would be liaising with the Medicines and Healthcare products Regulatory Agency. A spokesperson for the DH told The Pharmaceutical Journal that both medicines regulators and the providers of any new scheme will have the power to charge fees for regulatory work but that any fees under the new scheme are yet to be determined.

There was universal agreement that there is a need for more evidence and randomised controlled trials of e-cigarettes.  

Following the meeting, chairman of the APPG Kevin Barron said in a statement that e-cigarettes have the potential to play a major role in helping people to quit smoking. “However, for that potential to be realised we need to be clear about how safe they are”, he added. After the APPG has come to an agreement on a position, he said, “we will then engage with Government and others to make sure the potential of these products to reduce smoking is realised”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065325

Readers' comments (1)

  • Dear APPG, when considering your position on e cigarettes, please consider the they are not NRT and as such not a medicine. Please also consider that when developing your position on e cigarettes that you need to consult users. between medical regulation and the TPD, most products used by long term and exclusive users of e cigarettes will no longer be available. It is estimated that the number of exclusive e cigarettes users is 700000. It is an overwhelming ethical responsibility for you to actually ask these people why e cigarettes have worked.for them and ensure that you don't regulate what already works. Heavy handed medical regulation risks turning those who have successfully quit smoking back to smoking tobacco and discouraging existing smokers from making the switch. In each of these cases society incurs a huge public health loss.

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