Recently, there has been a number of high-profile cases and much media coverage of children with epilepsy gaining access to cannabis-based products for their condition. Following this the UK Government launched a review to consider the therapeutic and medicinal benefits of cannabis-based products for medicinal use. From 1 November 2018, a change in legislation, has meant that unlicensed cannabis-based medicinal products can legally be prescribed in some cases. We have written this blog to answer some of the frequently asked questions on this topic.
What is medicinal cannabis?
Medicinal cannabis refers to any sort of cannabis-based medicine used to relieve symptoms. Cannabis has many active chemical constituents. Two of these, tetrahydrocannabinol (THC) and cannabidiol (CBD), have been investigated for their medicinal value. Medicinal cannabis may be available in a range of forms, including as the actual plant material or an extract such as oils and capsules.
On 11 October 2018, the Home Secretary made a statement on the rescheduling of cannabis-based products for medicinal use. He said that:
“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 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.”
What has changed?
From 1 November 2018, changes to Misuse of Drugs legislation has enabled unlicensed cannabis-based products to be prescribed by some doctors for medicinal use, where there is a special clinical need.
Are the changes the same across the UK?
Yes, this issue is reserved to the UK Parliament. The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018 apply to England, Wales and Scotland. The Department of Health has confirmed that doctors in Northern Ireland will be able to prescribe on the same basis.
What products are available and are they licensed?
Sativex is the only cannabis-based medicinal product licensed for use in the UK. All other medicinal cannabis-based products are currently unlicensed medicines. Unlicensed medicines are known as “specials”. They can only be manufactured in, or imported into, the UK by a manufacturer or wholesale dealer that has a licence from the Medicines and Healthcare products Regulatory Agency (MHRA). Such products are expected to meet standards of good manufacturing practice.
The MHRA had published guidance on The supply, manufacture, importation and distribution of unlicensed cannabis-based products for medicinal use in humans ‘specials’.
Who can prescribe unlicensed cannabis-based products?
Only specialist doctors on the General Medical Council’s Specialist Register, for example neurologists and paediatricians can prescribe unlicensed cannabis-based products for medicinal use. These doctors should only make the decision to prescribe in their own area of practice and training. In addition, the decision to prescribe should be agreed by a multidisciplinary team.
Can GPs prescribe unlicensed cannabis-based products?
No, currently only specialist doctors on the General Medical Council’s Specialist Register can prescribe unlicensed cannabis-based medicines in the UK.
What conditions can unlicensed cannabis-based products be used for?
Specialist doctors will not be limited by condition when prescribing cannabis-based medicines. However, it is considered that initial guidance for clinicians will focus on its use in children with severe forms of epilepsy, people with chronic pain and to help with nausea from cancer treatment.
“it is expected that cannabis-based products for medicinal use should only be prescribed for indications where there is clear published evidence of benefit or UK Guidelines [such as those produced by the National Institute of Clinical Excellence NICE] and in patients where there is a clinical need which cannot be met by a licensed medicine and where established treatment options have been exhausted.”
Does this affect Sativex?
Sativex is a cannabis extract. It is the only licensed cannabis-based medicinal product available in the UK. Since 2010 it has been authorised by the MHRA as a treatment for spasticity in multiple sclerosis. Spasticity causes a person’s muscles to feel stiff, heavy and difficult to move. Sativex is listed under Schedule 4 of the Misuse of Drugs Regulations 2001 and is not covered by the definition of unlicensed cannabis-based products for medicinal in the Misuse of Drugs Regulations.
Although Sativex has a licence it is not generally used by the NHS in Scotland. This is because a submission has not been made to the Scottish Medicine Consortium (SMC). The SMC provides advice to NHSScotland about the value for patients of newly licensed medicines. NICE has advised that Sativex should not be used to treat spasticity in people with multiple sclerosis because it is not a cost-effective treatment.
Is there guidance on the use of cannabis-based products?
The Chief Medical Officer for Scotland has published guidance for clinicians following the re-scheduling of certain cannabis-based products for medicinal use.
NICE is currently developing guidance on Cannabis-based products for medicinal use. This is expected to be published in October 2019.
The British Paediatric Neurology Association has developed interim clinical guidance for clinicians, covering cannabis-based products for medicinal use in children and young people with epilepsy. This document also provides background information and information on how to access these products.
Where can I find out more?
- Letter from the Chief Medical Officer and NHS England about cannabis-based products for medicinal use
- Medical cannabis (and cannabis oils)
- Advisory Council on the Misuse of Drugs recommendations
- Cannabis Scheduling Review Part 1
- House of Commons Library briefing on the medical use of cannabis published 15 August 2018.
Lizzy Burgess, Senior Researcher, Health and Social Care.