Introduction
Following changes to the misuse of drugs legislation in 2018, cannabis-based products can be prescribed by some doctors for medicinal use where there is special clinical need. SPICe published a blog following the change in legislation in November 2018, outlining the changes and providing context around medicinal cannabis.
Since 2018, multiple news stories have described situations where patients have still been unable to access specific medicinal-cannabis products. A related public petition (PE1884: Make whole plant cannabis oil available on the NHS or alternative funding put in place) is currently under consideration by the Citizen Participation and Public Petitions Committee.
This blog will explain how the prescription of medical cannabis currently works in Scotland and some of the potential barriers around prescribing these products. You can use the contents menu below to navigate to the questions you are most interested in.
What cannabis-based medical products are licensed in the UK?
Three cannabis-based medical products are licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. These are Epidyolex, Sativex, and Nabilone.
Epidyolex, Sativex, and Nabilone have been licensed for the following conditions:
- Sativex is licensed to treat spasticity in adults with Multiple Sclerosis who have been unresponsive to standard anti-spasticity medication.
- Nabilone is licensed for treatment-resistant nausea and vomiting caused by chemotherapy.
- Epidyolex is licensed for the treatment of seizures associated with two forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.
Can you get Epidyolex, Sativex, and Nabilone on the NHS in Scotland?
Only Epidyolex is recommended for prescription by the NHS in Scotland. Before a medicine can be prescribed routinely in Scotland, it has to be accepted for use by the Scottish Medicines Consortium (SMC). The SMC reviews medicines that are licensed by the MHRA or the European Medicines Agency (EMA).
The SMC accepts Epidyolex as an add-on therapy with clobazam, a benzodiazepine, for seizures associated with Lennox Gastaut syndrome and Dravet syndrome, both rare forms of epilepsy, in patients aged 2+. The SMC have published public summaries of their decision for Lennox-Gastaut syndrome and Dravet syndrome.
Epidyolex was under consideration by the SMC as an add-on therapy for seizures associated with Tuberous Sclerosis Complex (TSC) in patients aged 2+. On 7 February 2022, the SMC announced that Epidyolex has been accepted for this use within NHS Scotland.
Sativex is not recommended for use in NHS Scotland as an add-on treatment for patients with moderate-to-severe and treatment-resistant spasticity caused by Multiple Sclerosis. The SMC states that this is due to the holder of the NHS marketing authorisation not making a submission for this product. Individual doctors may be willing to prescribe Sativex without SMC recommendation. Sativex can also be accessed on a private prescription.
In England, clinical guidance and/or recommendations for these products has been published by the National Institute for Health and Care Excellence (NICE). The All Wales Therapeutics and Toxicology Centre has made recommendations and/or published guidance on Sativex and on Epidyolex for the treatment of seizures associated with TSC, for Dravet syndrome, and for Lennox-Gastaut syndrome. The Department of Health, Social Services and Public Safety in Northern Ireland have also made recommendations for Epidyolex and Sativex.
What are unlicensed products?
All cannabis-related products for medicinal use that do not have market authorisation (i.e. those other than Sativex, Nabilone, and Epidyolex) are unlicensed medicines.
Unlicensed medicines can be legally prescribed if there is a special clinical need.
Who can prescribe unlicensed cannabis-based products?
Only specialist doctors on the General Medical Council’s Special Register can prescribed unlicensed cannabis-based products for medicinal use. GPs cannot prescribe them.
Why aren’t more people getting prescribed medicinal cannabis?
Barriers to accessing cannabis-based products for medicinal use on NHS prescription: Findings and Recommendations, published in August 2019 by NHS England and NHS Improvement, suggested that weak clinical evidence has prevented the prescription of cannabis-based products for medical use (CBPMs) by clinicians. A response to a FOI request on why Scottish patients were not included in the review has been published by the Scottish Government.
These barriers are similar in Scotland, as highlighted by the Chief Pharmaceutical Officer for Scotland’s written submission for PE1884 in August 2021.
The Chief Pharmaceutical Officer stated that many specialist doctors have concerns around the ‘safety and efficacy’ of cannabis-based medical products and the ‘lack of robust evidence on their use’. Unlicensed products have not been through the same tests for safety, efficacy, and quality as licensed medicines. Their prescription therefore puts greater responsibility on the prescribing doctor, who is ‘professionally and clinically responsible’ for any medicines that they prescribe.
What guidelines and evidence are available?
In November 2019, NICE published guidance on prescribing CBPMs in England. The guidance focused on the current evidence to support cannabis-based medical products in treating intractable nausea and vomiting, chronic pain, spasticity, and severe-treatment resistant epilepsy.
NICE made multiple recommendations based on the evidence available, including:
- To consider the use of nabilone as an add-on (additional) treatment for adults (18+) with nausea and vomiting caused by chemotherapy, which has been resistant to conventional antiemetics.
- To not offer nabilone, dronabinol, THC, or a combination of CBD with THC to treat chronic pain in adults.
- To offer a 4-week trial of THC:CBD spray as a treatment for moderate-to-severe spasticity in adults with Multiple Sclerosis under specified conditions.
A clarification of guidance was released in March 2021. While NICE found ‘insufficient evidence of safety and effectiveness to support a population-wide practice recommendation’ of cannabis-based medical products for severe treatment-resistant epilepsy, NICE clarified that healthcare professionals should not feel prevented from considering the use of unlicensed products if appropriate for individual patients.
To support the Citizen Participation and Public Petitions Committee’s consideration of PE1884, SPICe has published a literature review of international evidence around the use of CBPMs for epilepsy.
What is the Scottish Government’s response?
The regulation of medicines and medicinal products, under the Misuse of Drugs Act 1971, is reserved to the UK Government and is the responsibility of the MHRA.
The Cabinet Secretary for Health and Social Care, Humza Yousaf MSP, responded to recent written questions on medicinal cannabis and outlined the Scottish Government’s position.
In September 2021, the Cabinet Secretary was asked what action the Scottish Government can take to improve the “confidence in medicinal cannabinoids among clinicians prescribing treatments for chronic pain” and to improve the availability and affordability of medicinal cannabis in Scotland. The Cabinet Secretary responded that, in light of the current lack of clinical evidence base around CBPMs, the Scottish Government is ‘encouraging companies to participate in clinical trials so that these products can be tested for quality, safety and efficacy.’
The Cabinet Secretary provided an update on clinical trials in their January 2022 written submission for PE1884, again emphasising the Scottish Government’s encouragement of clinical trials. The National Institute for Health Research (NIHR) and NHS England are currently developing a programme of two randomised control trials (RCTs) into early-onset epilepsy. These trials will be open to patients in Scotland and will compare medicines that contain CBD only with those that contain CBD plus THC with placebos. The Cabinet Secretary stated that these trials will ‘examine the quality, safety and efficacy’ of the use of CBPMs in epilepsy and will help to answer whether adding THC can improve the anti-epileptic properties of CBD. Furthermore, expanding the evidence base will enable the manufacturers of these products to apply for market authorisation from the MHRA. Products could potentially become more widely available as a result, but this depends on the outcomes of the trials and if they meet NHS requirements. As the RCTs are in development, further information is not yet available.
The Cabinet Secretary also noted that he has written to the UK Government’s Secretary of State for Health and Social Care, Sajid Javid MP, to discuss the need to build the evidence base for CBPMs and how the UK and Scottish Government could together work to achieve this.
While the regulation of medicines and medicinal products is a reserved power, funding for cannabis-based products through NHS prescriptions is a devolved issue.
In January 2022, the Cabinet Secretary was asked about what financial support the Scottish Government was willing to make available to fund CBPMs for children currently relying on private prescriptions for treatment-resistant epilepsy. The Cabinet Secretary answered that the Scottish Government has considered options for funding private prescriptions in these instances; however, the Scottish Government continues to believe that this would be ‘inappropriate for the costs associated with a private prescription to be paid by the NHS’.
Where I can I find out more?
Information on the regulation of medicines in Scotland can be found in the SPICe briefing Medicines in Scotland.
The House of Commons Library has published a briefing on the medical use of cannabis. This included information on the Medicinal Cannabis (Access) Bill currently being considered by the House of Commons.
Cristina Marini, SPICe Trainee