No new licence applications for e-cigarettes since UK medicines regulator changed its guidance

The medicines regulator has not received any applications from companies to licence e-cigarettes as medicines to aid smoking cessation, since regulatory guidance was updated six months ago, The Pharmaceutical Journal has learned.

In October 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) published updated guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines to support smoking cessation.

At the time, the Department of Health and Social Care said that the update“paves the way” for medicinally licensed e-cigarette products to be prescribed on the NHS, in what would be a “world first”.

The MHRA said the guidance, which was first published in December 2017, related to “quality standards for dose uniformity, non-clinical toxicological data requirements, and the design of the clinical pharmacokinetic studies”.

However, in a statement made to The Pharmaceutical Journal on 5 April 2022, the MHRA said that it was yet to receive any licensing applications from manufacturers since the update.

“Since we published our updated guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines to support smoking cessation, there has been much interest from companies who wish to achieve regulatory approval.

“While no new licence applications from industry have yet been submitted, we are providing ongoing advice to companies and are ready to promptly assess any application we receive,” it said.

“The MHRA recognises that some companies producing or developing e-cigarettes may be unfamiliar with the evidential requirements of medicines and medical devices regulation,” the statement continued, adding that the MHRA encourages these companies “to contact us for regulatory and scientific advice as soon as possible”.

Robert West, professor of health psychology and director of tobacco studies at University College London, said: “As predicted, the regulatory process still represents an insuperable barrier for most e-cigarette manufacturers.

“The cost of putting together a dossier is beyond their means, and the idea of sharing the cost across manufacturers, while laudable, always seemed unrealistic in a competitive marketplace.

“An added disincentive is that the market for prescribed e-cigarettes is likely to be small compared with the over-the-counter market.

“A major concern when the new regulatory process was announced was that it would be the tobacco industry, with its deep pockets, that would take advantage, and that remains the case.”

Deborah Arnott, chief executive of public health charity Action on Smoking and Health, said: “Making an application for a medicinal license requires the pulling together of a very detailed dossier which can take significantly longer than six months.

“That no applications have yet been made is no reflection on consumer e-cigarettes currently on the market, which already meet safety standards which are set and overseen by the MHRA.

“Around 3.6 million people use e-cigarettes in Great Britain, so if there were serious safety concerns about e-cigarettes currently on the market we would have expected the MHRA’s yellow card monitoring system to have picked them up by now.”

In June 2021, draft guidelines produced by the National Institute for Health and Care Excellence and Public Health England said that healthcare professionals, including pharmacists, should offer advice on e-cigarettes as a strategy for smoking cessation.

The guidance cited evidence indicating that nicotine-containing e-cigarettes are similarly effective to other smoking cessation options, such as nicotine replacement therapy.

However, research around the use of e-cigarettes has not always been positive. One study, which followed 32,000 adults over three years, found that e-cigarettes significantly increase the risk of chronic lung disease, while another found that people who use e-cigarettes alongside traditional cigarettes are no more likely to quit smoking in the long term than those who only smoke cigarettes.

In 2019, the European Respiratory Society declined to recommend the use of e-cigarettes as a smoking cessation aid, having said that doing so is “replacing a very harmful product with a less, but still harmful, product”.