UK Update: There seems to have been an explosion of dedicated shops and cafes selling CBD products over the last couple of years.

I can count at least five shops in a 500m radius near central Edinburgh where I live.

Selling CBD products has it difficulties. Products must not contain THC, the element of cannabis that has psychotoxic effects.

CBD products that are ingested (tinctures, drops and so on) are considered a ‘novel food’. They require authorisation, and while the Food Standards Agency in England introduced a 31 March 2021 cut off date for applications in order to allow these products to remain on the market pending approval only four manufacturers applied.

No such process was introduced in Scotland, and Food Standards Scotland has said they will make their own assessment. For now, no CBD ingestibles have received approval north or south of the border.

The question is: should manufacturers still pursue this route to growth, or is it, as producers Leafcann argue, a distraction?

Medical cannabis is an area that they argue promises better prospects. No doubt this is the rationale behind the partnership between Craig Farm in the Scottish Borders and Hilltop Leaf, who obtained planning permission and development funding from South of Scotland Enterprise to establish a cannabis farm.

They are now seeking licences to grow from the Home Office and Medicines and Healthcare products Regulatory Agency. Only two other HO licences have been given out in the UK to date: the first in 1998 to GW Pharma (bought by Jazz Pharmaceuticals in February this year); the second earlier this year to Jersey based Northern Leaf.

So, why is medical cannabis potentially a more attractive investment?

Well, since November 2018 medical cannabis has been approved for use in the UK: Epidiolex and Sativex produced by GW Pharma are the two cannabis-based medicines currently approved for use by the NHS in England, although only Epidiolex has been approved for use by the NHS in Scotland.

Private health providers are said to be seeing strong demand. Sapphire Medical Clinic opened its doors in Stirling earlier this year to much fanfare.

But since legalisation, observers point to the fact that very few NHS prescriptions have been issued, and still only a limited number by private providers (costing upwards of £1,000 per month). That is said to be driving patients to continue to go overseas or source products on the black market.

They highlight a number of barriers to prescribing medical cannabis, such as a perceived lack of scientific evidence about the benefits in the face of long held beliefs about the harms of such products, and the additional bureaucracy and issues of liability for prescribers. What they say is needed is more patient focused research.

That is precisely what has driven a new recommendation published earlier this month by the British Medical Journal. This has given a tentative thumbs up to non-inhaled medical cannabis.

It concludes that for patients living with chronic pain, if standard care is proving insufficient, they recommend offering a trial of these products.

The study behind the new recommendation (BMJ 2021; 374: n2040) is a stark reminder that chronic pain is a significant global health issue: 10-14% of the UK population report moderate to severe chronic pain (i.e. lasting more than three months), and the figure is 20% in North America, Australia and Europe. It is more common amongst women, the elderly, veterans, indigenous populations and the socioeconomically disadvantaged. Cannabinoids may be one of the answers to this, as they are thought to affect pain or the perception of pain.

The study focused on patient experience. It concluded that in the proportion of people living with chronic pain there was:

• a small increase in those experiencing an important improvement in pain and sleep quality;
• a very small increase in those experiencing an important improvement in physical function;
• no improvement in emotional, role or social functioning;
• a small to very small increase in those experiencing adverse effects (cognitive impairment, vomiting, drowsiness, impaired attention, nausea and dizziness).

The recommendation reflects a high value placed on small to very small improvements in self-reported pain, physical functioning and sleep quality, and a willingness to accept a very small to modest risk of limited transient adverse effects to achieve those improvements.

However, outcomes are necessarily subjective. A number of key questions are left for future study, such as the effect on younger people, the benefits of inhaled cannabis (which the study did not look at), and prolonged use.

The question is whether this latest “maybe” is enough to address historic concerns and encourage uptake by clinicians and patients.

Those at the commercial end of the spectrum will be hoping so.

By Joanna Fulton, Burness Paull LLP, Scotland, a Transatlantic Law International Affiliated Firm.  

For further information or for any assistance please contact ukscotland@transatlanticlaw.com

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