Is medical cannabis legal in the UK?
As mentioned above, cannabis-based medicines were officially legalised in the UK on the 1st of November 2018. The landmark law change followed months of high-profile campaigning, perhaps most notably by the parents of Alfie Dingley and Billy Caldwell, two young boys who live with rare forms of treatment-resistant epilepsy.
Since the legalisation of medical cannabis in the UK, an estimated 45,000 patients have received a prescription. However, the vast majority of these patients access their medicines via private clinics, with only a handful of patients receiving a prescription through the NHS. The lack of NHS prescribing is typically attributed to a paucity of clinical research and limited recommendations from the National Institute for Health and Care Excellence (NICE).
But the announcement of two long-awaited, NHS-backed clinical trials has triggered hope that cannabis-based medicines may soon become more widely available.
The importance of medical cannabis research
Cannabis has been a staple in traditional medicine for thousands of years. The plant was used by ancient societies all around the globe for the treatment of a wide range of ailments; however, almost worldwide prohibition of the plant in the 20th century had a significant impact on scientific and clinical research into the plant and its derivatives. These limitations continue to have an impact on medical cannabis access to this day.
In October 2024, it was announced that two clinical trials, backed by the NHS and the National Institute for Health and Care Research (NIHR), would assess the potential of cannabis-based medicines in the treatment of early-onset and generalised, treatment-resistant epilepsies.
Medical cannabis and epilepsy
Current evidence indicates that cannabis-based medicines containing both CBD and THC can be beneficial in the treatment of some forms of epilepsy. Lennox-Gastaut syndrome and Dravet syndrome are two of a small number of conditions for which the NICE recommends the use of medical cannabis.
What are the aims of the clinical trials?
The two clinical trials scheduled to begin in 2025 compare the effects of CBD (MRX2) and CBD with small amounts of THC (MRX2T) against a placebo. Reportedly, 500 adults and children with treatment-resistant epilepsies will be enrolled in the trials to assess the safety and efficacy of medical cannabis formulations for reducing seizures and their impact on cognition, quality of life, level of behaviour and anxiety, sleep quality, and parental stress.
The Phase III clinical trials will be conducted by University College London (UCL) and Great Ormond Street Hopsital (GOSH) and trial products will be developed by Ananda Developments plc. They will be the largest studies of their kind to date and will represent the most significant UK trials into medical cannabis for epilepsy since research conducted by GW Pharmaceuticals which examined the potential of Epidyolex (a CBD-based medical cannabis product).
What are the potential benefits of the trials?
In addition to yielding valuable clinical evidence for the use of medical cannabis in the treatment of epilepsy, these trials will also assess the cost-effectiveness of these formulations from the perspective of the NHS and Personal Social Services. If successful, these trials could pave the way for expanded access to medical cannabis through the NHS.
Medical cannabis research and Releaf
Conducting clinical trials of medical cannabis products is a complex process that can take years of preparation. However, this is not the only kind of research of value. Observational data collected from current medical cannabis patients can also help to provide us with valuable insights into the potential benefits of medical cannabis treatment. And at Releaf, we will soon be launching our own research initiative to this end.
We will soon be asking new patients to complete disease-specific questionnaires, alongside a EQ-5D questionnaire, at intake and at three-month intervals following the initiation of their medical cannabis treatment. By tracking the long-term outcomes of our patients, we hope this data will help to further inform healthcare providers, policymakers, and researchers about the potential of medical cannabis.
Final thoughts
The clinical trials scheduled to begin this year represent an important step in medical cannabis research in the UK. But there is still more to be done. Learn more about how you can help to better our understanding of cannabis-based medicines and their potential in treating a range of conditions and symptoms.