A therapy area yet to develop is the specials prescribing of cannabis-based products for medicinal use (CBPMs). This became possible from1 November 2018 following their rescheduling under The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018.4

However, data for England at the start of 2019 suggests only a handful of CBPMs were dispensed in the community. In part, this is due to doctors being unfamiliar with prescribing medicinal cannabis around aspects such as indication, preparations and dose. NICE is scheduled to publish guidance in October 2019.5

But to further understand why CBPM prescribing is not happening, it helps to look at the conditions that were set out in the MHRA guidance, ‘The supply of unlicensed cannabis-based products for medicinal use in humans’, published in October 2018.6

No market authorisations have as yet been granted for CBPMs, so the only supply route is as a special. Among the requirements are:6

·       The prescriber must be a specialist doctor registered on the General Medical Council (GMC) Specialist Register to be able to issue prescriptions for unlicensed CBPMs.

·       As a specials product, the producer/supplier must provide a certificate of Analysis (CoA) and declare the concentration/ratio of THC/CBD (tetrahydrocannabinol and cannabidiol)

·       An unlicensed CBPM may only be supplied in order to meet the special needs of an individual patient – this means that the unlicensed CBPM product should not be supplied where a licensed medicinal product can meet those special needs.

·       To import a CBPM, the specialist importer must give the MHRA at least 28 days’ notice and go through a specialist importer’s customs clearance process.

The responsibility for deciding whether an individual patient has “special needs” which a licensed product cannot meet is a matter for the doctor listed on the GMC Specialist Register, responsible for the patient’s care.6

However, “anyone supplying an unlicensed CBPM where an equivalent licensed medicinal product is available must be satisfied as to the existence of a special need for the unlicensed CBPM.”