The achievability of a UK medicinal licence

A medicinally-authorized e-cigarette has been a topic of discussion since before the first Summit in 2013.  There were those who argued that only medicinally-licensed e-cigarettes should be on the market, while others believed that a medicinal-only marketplace would be accessible only for the big tobacco companies – who arguably had the least incentive to lead a revolution against combustible cigarettes.  MHRA has taken multiple steps to encourage the filing of a medicinal application for an e-cigarette, culminating in late 2021 in the publication of an updated guidance document, announced by the MHRA in a Press Release entitled “E-cigarettes could be prescribed on the NHS in world first.”  The recent Kahn Review has also recommended the addition of medicinally-licensed e-cigarettes, as a vehicle for increasing general practitioner and other healthcare provider confidence in vaping.  Is a medicinally-licensed e-cigarette possible?  Is it, in fact, only the province of big tobacco?  David Graham provides the perspective of an independent company that has successfully navigated FDA’s PMTA process, addressing the achievability of a UK medicinal license and drawing parallels and distinctions between a UK medicinal application and the US PMTA.