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.
BMA and RCGP statement on ‘Cancard’
Some concerns have been raised by practices about the Cancard UK website and its proposed ‘GP endorsed’ ID card. The website offers the ability to apply for:
"A holographic photo ID card. Designed in collaboration with GPs and verified at the patient's surgery. The card is for people who qualify for a legal prescription but are unable to afford one."
Applications are said to open on 1 November 2020.
The Medicinal Cannabis holographic photo ID card is being offered by Cancard UK to patients who:
- have a diagnosis (confirmed by their GP) that is currently being prescribed for privately
- have tried two types of prescription medication or have discussed and discounted these options based on side effect profile or dependence concerns
- are unable to afford a private prescription
- are required to be in possession of a small amount of Cannabis in order to manage their symptoms
- are at risk of criminalisation.
The BMA and RCGP supports the use of 'cannabis-based products for medicinal use in humans' under the supervision of specialist clinicians or prescription of MHRA authorised licenced products by doctors who have the necessary clinical experience and competences.
These products must have been produced in accordance with the necessary standards for the production of medicinal products in the UK in order to ensure their safety and authenticity. We also support the call for further research into the safety and potential indications for use of these medical products.
The BMA and RCGP cannot however support the use of the Cancard, nor the suggestion that UK registered GPs sign a declaration confirming a diagnosis in order for the card to be issued.
The Cancard UK website states that the Cancard has been designed in collaboration with GPs but as far as we are aware there is no formal endorsement from the Royal College of GPs, nor has the BMA, as your trade union, been consulted.
Whilst we sympathise with patients who struggle to pay a private prescription charge, we do not believe that this is a justifiable reason to encourage the purchase of unregulated unlicensed cannabis products from unregulated or illegal dealers.
If a patient is deemed to meet the criteria for an NHS prescription for an MHRA authorised prescriptible product then this may be issued where appropriate. Those patients on low incomes or with medical conditions qualifying for prescription charge exemption will be exempt from prescription charge in line with current regulations.