From today, specialist clinicians can prescribe cannabis-based medicines in the UK to patients with “exceptional clinical need”. They will no longer need to apply to an expert panel for a licence.
The UK government has rescheduled cannabis-based medicines under the Misuse of Drugs regulations 2001. They are now no longer listed under Schedule 1 alongside substances considered to have no therapeutic effect.
Specialist clinicians will not be limited by condition when prescribing cannabis-based medicines. However, they will need to ensure that there is clear evidence of a benefit and that all other available treatment options have been unsuccessful.
Prescription of these medicines must also be in line with the available clinical guidance. The British Paediatric Neurology Association (BPNA) published guidance yesterday for use of this medicine in children with severe forms of epilepsy. This is one of three conditions that guidance will focus on. The Royal College of Physicians (RCP) has published guidance on use of cannabis-based medicines for chronic pain and nausea from cancer treatment.
‘Extremely restrictive’
The change in law has been welcomed by many organisations. However, some organisations like Epilepsy Action are concerned over the restrictiveness of the guidance provided. The BPNA has stated that it does not recommend the prescription of non-licensed cannabis-based products for medicinal use other than Epidiolex.
Epidiolex is the brand name for a cannabidiol (CBD) medicinal product. This is only one type of cannabis-based medicine. This medicine does not yet have a licence for use in the UK.
Epidiolex was recently approved by the Food and Drug Administration (FDA) in the US as a medical product. A decision is expected from the European Medicines Agency (EMA) next year for its use in Europe.
Epilepsy Action deputy chief executive, Simon Wigglesworth said: “Today’s change in the law should open the door for some children and adults with severe epilepsy to access potentially life-changing treatment.
“While this change is an important step forward, the guidance we have seen so far on how it will work in practice seems extremely restrictive.
“It suggests that cannabis-based medicines will only be an option for a very limited number of people with epilepsy – children with Dravet or Lennox Gastaut syndromes. Though this is welcome, there are children and adults with other complex and treatment-resistant epilepsy syndromes who could potentially also benefit.”
‘A timely and safe manner’
Epilepsy Action added that it recognises that good evidence of the effectiveness of cannabis-based medicines is currently limited to a few rare childhood epilepsy syndromes.
However, the patient-led organisation added that adults and children with other treatment-resistant epilepsies should also be able to access these medicines. This is in cases where there is some evidence of potential effectiveness and no other treatment has worked. The organisation also stressed that this should be done under the care of an epilepsy specialist and closely monitored.
“It will be down to the regulatory bodies, clinicians and commissioners to ensure that patients with a clear clinical need can access these medicines in a timely and safe manner,” Epilepsy Action said.
The National Institute for health and Care Excellence (NICE) is expected to publish guidelines about cannabis-based medicines later in 2019.
‘Not satisfactory’
The move to reschedule cannabis-based medicines was sparked in June this year. Twelve-year-old Billy Caldwell had his cannabis oil confiscated at Heathrow airport by the Home Office.
After he was admitted to hospital days later, he was issued with a special 20-day licence for his cannabis oil. As well as CBD, the cannabis oil that Billy was taking contained another part of the cannabis plant called tetrahydrocannabinol (THC).
Home Secretary Sajid Javid called the situation with cannabis-based medicines “not satisfactory” and launched a review. The findings of the review supported the rescheduling of cannabis-based medicines.
The Medicines and Healthcare products Regulatory Agency (MHRA) provided a definition of what a cannabis-based medicine is ahead of the rescheduling.
The government has stated that this is not a move to legalise the recreational use of cannabis.