Prior to the change of the law on 1 November 2018, only cannabis-based products that had been given a marketing authorisation (product licence) by the medicines regulators, the Medicines and Healthcare products Regulatory Agency (MHRA) or European Medicines Agency could be prescribed. Before issuing a marketing authorisation the MHRA accesses all the available evidence on efficacy and safety arising out of pre-clinical research and clinical trials and evidence and information supplied by the manufacturer. The regulators also inspect the factory where the medicine is to be made, to make sure that supplies will be of a uniformly and consistently high standard.
The following cannabis-based products and related products received a marketing authorisation in the United Kingdom/European Union before 1 November 2018:
- Sativex - (produced by GW Pharmaceuticals) containing tetrahydrocannabinol (THC) and cannabidiol - holds a licence for spasticity in multiple sclerosis; and
- Nabilone - (multiple manufacturers) which contains a synthetic, non-natural cannabinoid which mimics THC, holds a marketing authorisation for nausea and vomiting caused by chemotherapy.
In addition, Epidiolex (also produced by GW Pharmaceuticals from cannabis) for two severe forms of intractable epilepsy (Lennox-Gastaut Syndrome or Dravet Syndrome), is currently being considered for a marketing authorisation by the European Medicines Agency.
The change in the law allows the prescription, by specialist doctors on the General Medical Council’s Specialist Register, of cannabis-based products that have not been through this rigorous process but that meet certain quality standards in cases where all licensed products have been considered and discounted and it is in the best interest of the patient. It also makes
it easier and will incentivise further research into the potential health benefits of cannabis-based products and the development of further licensed products for more routine use in the health service.