Less than one year since medical cannabis was legalised in the UK and just two months since the first medical cannabis clinic opened in London (as reported in our last blog post), a cannabis-based drug has been approved for use in the UK. Its approval may herald the acceptance of cannabis-based drugs into mainstream medicine across the country.

What is Epidyolex?

Epidyolex is a cannabis-based medicine for children suffering from Epilepsy. Cannabis-based drugs contain cannabidiol (CBD) which is one of the components of marijuana. According to the World Health Organization, “there is no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD”.   According to publicly available information, Epidyolex contains none of the psycho-active component of cannabis, a compound called tetrahydrocannabinol. The US Food and Drug Administration (FDA) approved Edpidyolexfor use in the US in June 2018.

Who is it aimed at?

Epidyolex may help individuals suffering from seizures resulting from two rare forms of epilepsy – Lennox-Gastaut syndrome (LGS) and Dravet syndrome. The Guardian states that these syndromes alone affect up to 50,000 children and young adults in Europe, including about 10,000 in the UK.

Patients with LGS and Dravet syndrome suffer multiple seizures a day and do not respond to many other available treatments. The syndromes have a high mortality rate and many patients die before they reach their early 20s.

The approval

Now, the manufacturer of Epidyolex has received approval from the European Medicines Agency and the European Commission for the drug to be given to sufferers aged two and older in the UK. The company has begun discussions with the UK’s National Institute for Health and Care Excellence (NICE) about making the drug available on the NHS.

The significance of the approval

Our previous blog post noted that while cannabis for medical use was legalised in November 2018, doctors have been reluctant to prescribe cannabis-based medicines in the UK because of the lack of clinical trial evidence of its benefits and safety.

The European Pharmaceutical Review reports that the decision to approve Epidyolex was based on the evidence of four randomised, controlled Phase III trials. This is of particular significance as it may act as a green light to doctors who were formerly reluctant to prescribe because they were not convinced of the medical benefits of cannabis-based medicines.

While this appears to be a step forward however, BBC News reports that Ley Sander, Medical Director of the Epilepsy Society and Professor of Neurology at University College London, has concerns that: ‘medicinal cannabis […] still remains a medical minefield and there are many hurdles ahead’. Indeed, the next question is whether the drug is approved for reimbursement on the NHS. If it is not, as at our last time of writing, parents of sick children in the UK will still need to rely upon private clinics to access cannabis-based treatment.  


Julia Gillert is Of Counsel at Baker McKenzie's London office, and has shaped her practice to focus exclusively on regulatory matters affecting the Healthcare & Life Sciences industry.


India-Rose May is a Trainee in Baker McKenzie's London office.