UK-based CBD companies may feel they have had a rough ride of late. From operating within a light-touch regulatory regime, founded on the belief that CBD products were no different to any other readily available food supplement, the closing drawbridge that is the Food Standards Agency's (FSA) novel food application process has been a shock to the industry's system.
The process, which requires non-medicinal CBD products to be the subject of an application for authorisation has caused a stir within UK-CBD stocks and laid bare the industry's reliance on white-label goods. This has left many querying the real value behind some of the glitzy, celebrity-endorsed brands dominating the CBD landscape.
The longer-term consequences of the clampdown are difficult to predict. When announcing the publication of its list of products which have submitted a valid novel food application, the FSA confirmed the role of enforcement authorities and that it had recommended to local authorities that any products not on the list should be withdrawn from the market. Such products would be deemed “unsuitable for progressing to authorisation” or, in other words, dead in the water.
As one door closes, another opens
The UK CBD industry has, to date, catered to a wide variety of consumers. CBD can be found in a diverse range of products, from dog food to cosmetics. One of the largest and arguably sustainable customer bases, however, is consumers with some sort of health or therapeutic need for which they are unable to access medicinal cannabis.
One potential consequence of the FSA's drive to rein in the UK's CBD industry is reduced access to the previously available wide range of products. By 2022, it is now difficult to find a high street or retail centre between John o' Groats and Land's End without CBD products for sale. That position could dramatically change.
Medicinal cannabis products have been available since 2018
Cannabis-based products for medicinal use, or “CBPMs”, have been available for prescription in the UK since 2018; however, access is strictly limited through existing and bespoke regulatory controls. In addition to the regulatory barriers to access, funding has long been cited as a problem, with limited patient access through the UK's National Health Service. In drilling down the issue, a lack of UK-based research as to the efficacy of CBPMs is the starting point.
Several laudable initiatives have sought to plug the research gap, including Project Twenty21, which is the UK's largest observational medicinal cannabis study. However, observational studies have their limitations, which is why most have recently welcomed with open arms the UK Health Research Authority approved trial, Canpain.
Canpain is planned to run for three years and aims to conduct clinical trials involving up to 5,000 patients suffering from chronic pain. The trial will be the first of its kind in the UK and could be significant in opening access to CBPMs for the UK's estimated 1.4 million patients currently accessing cannabis through the illicit market.
Reliable data on the number of CBD consumers with some sort of therapeutic need is patchy, but as access to CBD products becomes more limited through enforcement of the novel food regime, access to CBD-based medicines could provide an important lifeline.
This could also present opportunities for the CBD industry, which until now has seen a benefit in its separation from the medicinal market. The industry must ask itself whether it is now time to explore the jump from consumer products to medicines.
Can a more agile CBD industry flourish and better serve patients?
No one would suggest that the development and marketing of a new medicinal product is a straightforward task. Although CBD is not a controlled drug in the UK, the position of the Home Office remains that it is difficult to produce CBD without any trace element of THC, which is controlled.
Consequently, it is usually necessary to begin the process of developing a CBD-based medicine with an application to the Home Office for a Schedule 1 controlled drug licence for research purposes. Further licences are likely to be necessary throughout the development process, including a Schedule 2 controlled drug licence for operating with CBPMs, as well as Manufacturers (Specials) and Distributors licences from the Medicines & Healthcare products Regulatory Agency (MHRA).
The regulatory hurdles are many, but the potential UK market – thought to be the largest untapped market in Europe – is significant. Turning to the development of CBD-based medicines could represent a lucrative opportunity for some of the brands which have, until now, limited their reach to what might be described as the lifestyle market.
That may not explain or justify the FSA's stance, and nor does it remove the urgent need to liberalise access to CBPMs. But for consumers with a therapeutic need, a more competitive UK CBD industry, agile in its ability to cross the barrier between the medicinal and non-medicinal worlds, can only be a good thing.
Originally Published by Open Access Government on 11 May 2022
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