Products classed as cannabis-based for medicinal use
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
- 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.
How patients access cannabis-based medicinal products
There are three ways for patients to access cannabis-based medicinal products:
- Doctors on the GMC specialist register can prescribe a cannabis-based medicinal product as an unlicensed ‘special’ medicinal product (see below);
- Participants in clinical trials for investigational medicinal products can be given a cannabis-based product for medicinal use without a marketing authorisation;
- Doctors can prescribe a medicinal product that has MHRA marketing authorisation (currently only Sativex in the UK).
Prescribing is only restricted to a doctor on the GMC specialist register where the cannabis-based product is an unlicensed ‘special’ medicinal product for use by a specific patient.
Once a product receives a licence from the MHRA, it will be available for prescription in the same way as any other Schedule 2 drug.
Due to the limited evidence base and their unlicensed nature, prescribing of cannabis-based products for medicinal use is restricted to only those clinicians listed on the GMC specialist register.
Who can issue prescriptions
Only doctors on the specialist register will be able to sign prescriptions. NHS England will issue further guidance on this.