Spectrum Therapeutics UK lifts the lid here on a pilot analysis of medicinal cannabis use that will run in Denmark until January 2022
It has been over a year since unlicensed cannabis-based medicinal products (medical cannabis or CBMPs) were rescheduled in the UK. Yet since this change, many people are still publicly campaigning to better access these treatments through the National Health Service (NHS) or by private prescription.
While it might sound like Britain is breaking new ground, many countries have gone before us. In Canada, at the end of September 2018, there were 342,103 medical cannabis patients registered on Health Canada’s database.1 The Government of Australia has approved over 17,300 applications for unlicensed medicinal cannabis products.2 They are doing this, not because they don’t have all the same challenges we find in the UK, but because they are trying to address patient demand for medical cannabis and accumulate real-world evidence.
Denmark is a comparable, regulated European healthcare system that faced the same scenario we are seeing in the UK, with a limited number of clinicians able to prescribe a limited range of products to a limited patient population in “medical extremis”. While it is widely acknowledged that more robust evidence on unlicensed cannabis-based products for medicinal use in humans is needed, countries like Denmark are exploring pilot programmes which are increasingly being viewed as an effective mechanism for controlled access.
In Denmark a unanimous government vote was passed to implement its first, four-year pilot programme, supporting doctors to prescribe medicinal cannabis. This is available to registered patients and funded within Denmark’s healthcare system. Patient-Reported Outcomes (PROs) and adverse events can also be tracked.
The pilot has been running since January 2018 and will run until January 2022. Eligible patients include those who have failed to respond to currently licensed treatments for:
- Painful spasms caused by multiple sclerosis;
- Painful spasms caused by spinal cord damage;
- Chemotherapy-induced nausea;
- Neuropathic pain.
In 2018, 6,778 prescriptions for CBMPs were fulfilled for 1,336 patients in Denmark. The average age of patients was 41 – 64, with the most common condition prescribed for being neuropathic pain. The pilot has been gathering further momentum as 9,490 prescriptions for 2,104 patients were made within the first quarter of 2019.3
It has provided a means of controlled, regulated access to legal, medicinal cannabis for those with unmet needs, and is creating evidence of PROs and adverse events. In the first year of the pilot programme, the Danish Medicines Agency did not identify any safety problems with these products, and non-serious side effects including dizziness, nausea and concentration problems did not cause the agency to take measures to minimise the risks of the products.4
As the UK continues to explore CBMPs, we should look abroad for inspiration. A “Danish model” would provide an interim solution while clinical trial evidence is developed, addressing patient demand and generating real-world evidence and clinical experience.
1 Health Canada. Market data under the Access to Cannabis for Medical Purposes Regulations. Available at: https://www.canada.ca/en/health-canada/services/drugs-medication/cannabi… (Last accessed December 2019).
2 Therapeutic Goods Administration. Access to medicinal cannabis. Available at: https://www.tga.gov.au/access-medicinal-cannabis-products-1 (Last accessed December 2019).
3 Danish Medicines Agency. Medicinal cannabis pilot programme. Available at https://laegemiddelstyrelsen.dk/en/special/medicinal-cannabis/citizens/medicinal-cannabis-pilot-programme/# (Last accessed December 2019).
4 Danish Medicines Agency. Report on suspected side effects reported for medicinal cannabis. Available at https://laegemiddelstyrelsen.dk/en/news/2019/report-on-suspected-side-effects-reported-for-medicinal-cannabis/# (Last accessed December 2019).
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