Some manufacturers may struggle to overcome certain regulatory hurdles to licensing e-cigarettes in the UK as medical products – leaving the field to tobacco companies. That’s the warning from a number of experts after the Medicines and Healthcare Products Regulatory Agency (MHRA) opened up a route for e-cigarettes to be made available on prescription.
Christopher Snowdon of the Institute of Economic Affairs (IEA) told ECigIntelligence that it is likely only tobacco companies would succeed in putting their products through the licensing system.
Likewise, Robert West, professor of health psychology and director of tobacco studies at University College London, said he was not confident that “any e-cigarette manufacturer, independent of the tobacco industry, will have the resources to overcome these hurdles”.
“This could very easily lead to a situation where tobacco company e-cigarettes can be prescribed, while others cannot,” he added.
Consistent dosing ‘difficult to engineer’
Public health expert Clive Bates told ECigIntelligence that manufacturers could find it difficult to get a vaping product licensed, as they will need to show that they “meet realistic safety criteria…and are capable of helping people quit smoking”. He said there was scepticism as to whether the MHRA had set “realistic and reasonable standards to establish the equivalent of quality, safety and efficacy”.
“I am worried that the MHRA may have missed an opportunity here and has not made the process simple enough to generate more successful applications,” he said.
Bates explained that the regulator may be still “asking for information that is either unnecessary or too difficult to produce cost-effectively”, and it could have simplified the system in a way that would have encouraged more companies to go down this route.
He said one concern was the consistent dosing requirement, as this was difficult to engineer in a product that allows the user to control nicotine intake.
“Time will tell if any manufacturer finds the new guidance helpful and makes it through the process, but I hope it works as the country needs every possible option to meet the 2030 smoke-free target,” said Bates.
Closed systems favoured
Dame Parveen Kumar, who chairs the British Medical Association (BMA) board of science, said making e-cigarettes available through the National Health Service (NHS) “will not be a silver bullet in reducing smoking rates” and called for the government to look at broader measures.
“Increased levies on big tobacco firms would also ensure that they pay for the harm their products cause to people’s health by funding smoking cessation initiatives and public health campaigns,” she added.
Some experts suggested that closed systems, such as disposable e-cigarettes, would have more chance of being licensed than open systems. This, said Snowdon, was “because they are more consistent and less susceptible to human error”.
Bates agreed, saying: “It would be essential for the MHRA to evaluate the device and liquid together. That favours sealed disposable units and pod-based systems.”
A spokesperson for the MHRA told ECigIntelligence that once a company submits a marketing authorisation application, the standard national timeline for applications is 150 days, plus any time needed by the company to answer questions that arise during the assessment. However, they denied disclosing whether the regulator had already started talks with manufacturers due to commercial confidentiality.
What This Means: The MHRA’s updated “Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines” suggests e-cigarettes may be made available for medicinal purposes in strengths and volumes greater than those currently permitted. Indeed, Clive Bates said one of the benefits is that products not allowed under the EU Tobacco Products Directive (TPD) could be authorised by this route, including those with stronger nicotine concentrations than the TPD limit of 20 mg/ml.
However, experts said that far from being the regulatory novelty some headlines had suggested, the medical licensing approach had been an option for manufacturers since 2013. However, it was and remained “expensive and time-consuming”, and it was hoped that the MHRA might have made some improvements to the process.
– Antonia di Lorenzo ECigIntelligence staff