CBD, Europe, News, Regulatory, UK

‘Time is right’ for UK government to push framework advancing CBD

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INTERVIEW: Andy Yates is Pharmacy Associate at the UK-based Association for the Cannabinoids Industry (ACI), which assists companies looking to enter the UK and EU markets. He has more than 15 years’ pharma experience in medical, commercial, business development and strategy. A UK pharmacist, Yates received his PhD in cannabinoid medicinal chemistry from the University of Nottingham. He has extensive experience in all aspects of medicine development programs and has been responsible for multiple collaborative initiatives among academia, the biotechnology sector and peer pharma. In addition to his responsibilities at ACI, Yates runs an independent pharmaceutical consultancy. He holds an Honorary Lectureship at Keele University.

HempToday: You’ve referred to the situation in the UK as a ‘quiet cannabis revolution.’ What’s quiet about it?

Andy Yates: The cannabis revolution that has happened within the UK has happened either serendipitously or in response to a specific event, rather than through strategic or planned interventions at a government level. The legal cannabis industry has therefore grown almost silently in the background to the significant presence we now see.

HT: ACI expects UK CBD sales to hit £690 million (€800 million) this year. What’s behind the numbers?

AY: Prior to 2019 the size of the market within the UK was effectively unknown. Therefore the ACI in partnership with a global market insight and forecasting agency did a bottom-up analysis of the UK market to provide the first accurate estimate. We surveyed thousands of consumers and captured their reported usage of CBD; we benchmarked against know constants in similar markets (i.e. use of nicotine vaping and use of other supplementation) to apply discount factors; and surveyed average spend per month which was benchmarked against know price points for CBD products to produce a robust model leading to a marketplace forecast of £314 million (€364 million) in 2019.

By asking current consumers and consumers yet to try CBD what their predicted usage and spend would be going forward we were able to calculate a double-digit growth rate year-by-year. Given the impact of COVID-19 (particularly as we were hearing spontaneous reports that usage was increasing) we felt that in 2021 it was important that we checked our forecasts again and did further consumer survey work among thousands of participants to understand current usage patterns.

The headline figure of £690 million (€800 million) was indeed higher than the £526 million (€609 million) predicted by the 2019 data model, which aligned to what we were understanding from our members, that usage had increased during the COVID-19 pandemic.

HT: ACI has noted that UK regulation of CBD specifically is evolving. What’s still needed to set a level playing field?

AY: We believe the time is right for the UK Government to recognize the significant value and benefits that the industry brings to the UK. They need to provide a framework and regulations that encourage and support the established industry and foster new growth within our shores.

There are three regulatory areas in which the UK still needs to level up:
Short term – the FSA needs to rapidly assess the dossiers of the companies that have submitted a novel food authorization, by their deadline earlier this year, to provide certainty to those companies that have submitted a valid dossier (and likely to lead to approval) and those that haven’t (and therefore have not complied with novel food guidance and should be removed from the shelves).

Medium term – the Home Office needs to provide a workable definition of a maximum threshold for controlled substances (i.e. THC) in consumer CBD products that avoids any doubt that the finished product falls under the misuse of drugs laws within the UK. The current “zero” and “exempted product” definitions are too vague and not easily achievable. Working with our members, we have sent recommendations that a 0.03% (or maximum of 21 ug in a container) is functionally equivalent to “zero” and would avoid any of the current ambiguity.

Long term – we wish for UK CBD manufacturers to be able to use CBD that is extracted from crops grown in the UK as it currently has to be imported. Our “Green Shoots” report to the Taskforce for Innovation, Growth and Regulatory Reform (TIGRR) that has made the argument for this situation to change. It was great to see our recommendations adopted in the TIGRR report as one of the stand-alone recommendations to stimulate growth in the UK economy

HT: How do we “avoid any doubt” on the matter of THC in consumer products?

AY: The ACI has conducted a data-driven review of the literature and subsequent safety assessment (led by a toxicologist) of acceptable THC levels within CBD consumer products which we have submitted to the Advisory Council for the Misuse of Drugs (ACMD) who advise the Home Office to support a change in the current law and guidance. We are currently publishing our findings in a peer-reviewed journal. Our findings made the following recommendations to the ACMD:

That the Home Office issue guidance and amend existing legislation, to exempt from control products designed for the oral administration of cannabidiol, containing not more than 21 micrograms of controlled substances (THC and CBN compounds and their derivatives) or with a total concentration of not more than 0.03% controlled substances in undivided preparations.
• That 0.03% is established as the “threshold of zero controlled impurities” for CBD products, based on our safety assessment that lifetime exposure to contaminants at this limit would be indistinguishable from exposure to contaminants at ‘true zero’ in terms of toxicological and other relevant markers of drug action in humans.

There would be no requirement to report on controlled cannabinoids as may be present only as trace contaminants in products for consumer sale, as is also the case in regard to the presence of traces of opium alkaloids in poppy seeds. The cultivation of low-THC cannabis would continue to be controlled under license, monitored, and reported to the International Narcotics Control Board (INCB) as required under the 1961 and 1971 UN Drug Conventions regarding imports and exports.

HT: How does that level finally get set, in practice?

AY: Setting a permitted maximum level for controlled cannabinoids in consumer goods could be established through legislative change, such as by means of a statutory instrument amending the Misuse of Drugs Regulation 2001 after consultation with the Advisory Council for the Misuse of Drugs to exempt CBD-based products at defined thresholds. A maximum level could also be established simply by means of guidance from regulators without new legislation, as is presently the case in regard to the target level of 10 mg/kg agreed for the presence of morphine in poppy seeds.

HT: One of the recommendations in the “Green Shoots” report is that a dedicated agency be named to license and oversee the industry. What’s the best scenario there?

AY: We believe that in order to become a world-leading jurisdiction for all cannabinoid business activities it would be best served by a single dedicated cannabinoids regulator – a “National Cannabinoid Control Authority (NCCA)” – built upon expertise from several departments of state including the Home Office, Department for Environment, Food and Rural Affairs (DEFRA), Department of Health and Social Care (DHSC), and the Department for International Trade (DIT), combined with regulatory skills from the Medicines and Healthcare Regulatory Agency (MHRA), FSA and the Environment Agency (EA).

The NCCA would develop the experience to provide a single “front door” to the cannabinoid sector for applicants of all kinds. Consideration should be given for this agency to be a non-ministerial department so it could operate independently and without political interference, as the FSA or Forestry Commission do. The NCCA could provide a dedicated licensing branch and a surveillance and inspection function, with annual reports to Parliament and the sponsoring department. A dedicated licensing body could also be required to publish all applications and the full details of the licenses granted on a regular basis, as they are in Canada.

HT: The ACI safety consortium is at the heart of your novel food advisory services. Talk about the critical functions of the consortium.

AY: The ground-breaking safety consortium put in place by the ACI recognized that the CBD industry needed to step up to the increasing regulatory scrutiny that we asked for in relation to novel foods. Simultaneously we recognized that the financial and skill-based barrier to entry for increased regulatory rigor was going to be too high for many individual manufacturers of CBD products to achieve on their own.

Working directly with the Foods Standards Agency (FSA) and with scientific partners, with the expertise to carry out the specific work required, the ACI was able to put in place a series of studies using a representative CBD extract that supports the submission of multiple novel food dossiers that contained the vital safety data to enable the FSA to validate and ultimately approve our members’ products.

By syndicating this work the price point was significantly reduced, allowing CBD manufacturers to confidently produce relevant data for their individual dossier by sharing the cost with other consortium members.

HT: What has come out of the human clinical studies so far? What specifically was studied?

AY: The area of human clinical studies looking at CBD is vast. What I will highlight is there are already two licensed medical products that contain CBD on the market for childhood epilepsy (Epidyolex) and spasticity in multiple sclerosis (Sativex) which shows that for the right dose, in the right disease, the benefit-risk profile of CBD is sufficiently positive for medical regulators to approve it as a medicine.

Out of the many studies already completed, the strongest clinical evidence so far is for pain, anxiety and sleep. Importantly there are over 139 active human clinical trials ongoing in 21 different medical indications and 83 of these are in larger Phase 2 or Phase 3 trials; so the future looks bright for CBD in medical conditions.

HT: What is the level of awareness and understanding of the British consumer regarding CBD and CBD products? What’s needed to normalize CBD as a food in the UK?

YA: Awareness is good here in the UK and currently growing, with between one and two people in 10 having purchased a CBD product; and of those that have not used a CBD product, over half of them have expressed a willingness to try a CBD product in the future.

The most common reasons given for not trying a CBD product were related to a lack of certainty on the legal status of CBD and a perceived lack of regulation around the products. Initiatives outlined above will be clear drivers of awareness and normalization of this sector.

HT: Talk about the range of companies among your membership. Who is really looking seriously into the UK?

AY: We have members from all over the globe working in partnership with us at the ACI. All of them have a common interest and goal; to participate in the thriving CBD market here in the UK. I believe it is safe to say that all of our members are very serious about the UK CBD market, both for the short and medium-term value, but longer-term with the UK being seen as a global leader in consumer CBD regulations.

HT: How would you characterize ACI’s effectiveness so far?

AY: The ACI has been instrumental in establishing the importance of the market to consumers and business with our pivotal 2019 and 2021 reports into CBD usage, and has been on the front foot in working with UK regulators, particularly Food Standards Agency and the Home Office, to evolve the regulations in a fit-for-purpose way. This ensures consumers get access to the safest and highest quality products and the industry can operate in an environment with clear rules and regulations.

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