Prof. Giovannoni’s research at The Faculty of Medicine and Dentistry on the biological mechanisms by which compounds in cannabis control spasticity in multiple sclerosis patients led to changes in clinical guidelines in Wales and Ireland in 2014. In both countries, the licensed product Sativex®, developed based on our research, is now approved for use. This led to a 2018 recommendation by the Chief Medical Officer for England to change the scheduling of cannabinoid drugs from Schedule 1 drugs which are defined as having little or no therapeutic benefit. In 2015, the Department of Transport changed their drug driving legislation to accommodate patients prescribed Sativex®.
As a consequence of disease-related nerve damage, people with multiple sclerosis develop issues associated with lack of co-ordination of neural signalling leading to many symptoms. This includes muscle stiffness (spasticity), which occurs in about 95 per cent of people who develop multiple sclerosis (2-3 million people worldwide). This also develops following brain and spinal cord injury, stroke and cerebral palsy. Our work demonstrated that the tetrahydrocannabinol in cannabis and the CB1 cannabinoid receptor in the body’s cannabinoid system act together to regulate overactive nerve stimulation. This was also the basis of numerous clinical trials.
Sativex®, developed by GW pharmaceuticals UK has been approved for use in spasticity due to multiple sclerosis by the European Medicines Agency. The All Wales Therapeutic and Toxicology Centre took the view that: Sativex® is appropriate for specialist-only prescribing within NHS Wales for the indication under consideration. Sativex® was also authorised for use in patients with moderate to severe spasticity due to multiple sclerosis by the Health Products Regulatory Authority in Ireland in 2014.
Following the approval of Sativex® for use in spasticity for multiple sclerosis patients the Department of Transport released new drug driving rules for those prescribed Sativex® in 2015. Thus, people with multiple sclerosis who, in the opinion of a doctor, can drive safely are able to raise a statutory medical defence if stopped by the police. In 2018, Dame Sally Davis, the Chief Medical Officer for England recommended that: cannabis-based medicinal products are moved out of Schedule 1 of the Misuse of Drugs Regulations 2001 as Schedule 1 drugs by definition have little or no therapeutic potential. However, there is now conclusive evidence of medicinal benefit of cannabis-based products for certain medical conditions. Moving these drugs out of Schedule 1 would allow them to be prescribed under controlled conditions by registered practitioners for medical benefit.