As of 1 November 2018, the only cannabis-based medicine that had a marketing authorisation in the UK was Sativex (also known as nabiximols), an oral spray licenced for use by the MHRA (Medicines and Healthcare products Regulatory Agency) to treat spasticity in adults with Multiple Sclerosis. NICE (National Institute for Healthcare Excellence) do not consider Sativex to be a cost-effective treatment, and therefore its usage is limited in the NHS across the UK. However, the All Wales Medicine Strategy Group do recommend its use in Wales.
The 2018 Regulations introduce a definition of cannabis-based products for medicinal use. Only products meeting this definition will be rescheduled to Schedule 2. To constitute a cannabis-based product for medicinal use in humans, a product must satisfy three requirements:
- It needs to be a preparation or product which is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative;
- It is produced for medicinal use in humans and;
- Is a medicinal product, or a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product.
Any product that satisfies these three criteria is considered to be a ‘cannabis-based product for medicinal use in humans’ and is now a Schedule 2 drug under the 2001 Misuse of Drugs Regulations. These Regulations include the need to keep a controlled drug register, and safe custody requirements.