The plight of children affected by intractable epilepsy and the efforts of the families of Alfie Dingley and Billy Caldwell to access to medicinal cannabis led to a change in Government policy. In November 2018 medicinal cannabis was changed from Schedule 1 to Schedule 2 of the Misuse of Drugs Regulation 2001, allowing specialist doctors to prescribe it and for products to be available for further research to be conducted.
This rescheduling was widely welcomed but there was a failure to communicate what this would mean in practice for the availability of medicinal cannabis. Expectations were raised that these products would become widely available and there needs to be far clearer communication that this is not the case.
Very few prescriptions have been issued for medicinal cannabis since the rescheduling in November 2018. This is because most of these products are not licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA) and neither have they been approved by the National Institute for health and Care Excellence (NICE).
There are major gaps in the research base for medicinal cannabis in part because research was very difficult under the previous scheduling. There were restrictions on accessing products to conduct the robust clinical trials necessary to test efficacy and safety. Without a thorough research base products remain unlicensed and may only be prescribed if the individual prescribing doctor is satisfied that there is sufficient evidence for the product’s safety and efficacy for an individual patient.