The following chapter featured in Medical Cannabis & Cannabinoid Regulation 2024 and is awaiting update from the firm.

The cannabis industry is broadly split into two halves: the partially regulated CBD wellness sector, and the fully regulated medicinal cannabis sector.

There is no consolidated piece of legislation that directly governs cannabis in the UK; the laws and regulations that currently govern the practices in this jurisdiction are spread across numerous statutes.

The primary laws and regulations fall into the following categories.

• Controlled drugs legislation.
• Product class-specific legislation, applicable to the cannabinoid wellness sector (ie, food, vape and cosmetics laws).
• The Medicines and Healthcare products Regulatory Agency’s (MHRA) regime for medicinal products in relation to:
1. unlicensed medicines (namely “cannabis-based products for medicinal use” or CBPMs), which primarily relate to issues with prescribing, importation, manufacture, distribution and dispensing of CBPMs, and other regulatory bodies’ rules that interplay such as of the Care Quality Commission (CQC) and General Pharmaceutical Council (GPhC); and
2. general licensed medicine laws relating to elements such as clinical trials, regulatory approvals and pharmacovigilance.
• Ancillary legislation – for example, advertising rules (from the ASA and MHRA) relating to promotion of medicines, money laundering legislation that applies to UK professional services firms and investors in relation to (non-medical) cannabis markets, or jurisdictions with substantially different licensing regimes.

Controlled Drugs Legislation

The two primary pieces of legislation from which the controlled drugs laws stem are the Misuse of Drugs Act 1971 (MDA 1971) and the Misuse of Drugs Regulations 2001 (MDR 2001). These two pieces of legislation classify cannabis and cannabis resin as a Class B and Schedule 1 controlled substance, respectively – meaning that a licence from the Home Office is required for all activities involving the substance, from research to cultivation.

Aside from controlling the plant itself, these statutes also clarify that certain cannabinoids (compounds contained within the cannabis plant) are controlled. The omission of cannabidiol (CBD), among other minor cannabinoids, from this list has allowed for its use commercially and in the health and wellness space, as there are no criminal penalties for using, possessing or selling it.

On 1 November 2018, the UK legalised the use of medical cannabis through the rescheduling of certain types of medical cannabis product from Schedule 1 to Schedule 2. These Schedule 2 cannabis products are, almost exclusively, “unlicensed” as they have not been tested in clinical trials and therefore do not have a marketing authorisation or “product licence”. They are referred to in the legislation as “cannabis-based products for medicinal use in humans” (CBPMs), and this has meant that from 1 November 2018 there was a legal route for medical cannabis to be prescribed by doctors on the General Medical Council (GMC) Specialist Register for a variety of indications.

The result of the 2018 change in law was, however, somewhat of an anti-climax in practice. Restrictive guidelines, together with the fact that the legislative change did not authorise general practitioners (ie, first port-of-call doctors operating within the UK National Health Service, the NHS) to issue initial prescriptions, has meant that only a handful of prescriptions for unlicensed CBPMs have been issued on the NHS to date.

Private prescription of CBPMs has shown far greater overall numbers and growth, with 4,469 prescriptions reported to have been written in 2020, increasing to 42,393 in 2021 and to 46,846 in the first six months of 2022, with some reports suggesting that the figure for the first nine months of 2022 was 182,010.

CBD Wellness Products: Class-Specific Legislation

Consumables

CBD wellness products are subject to the same legislative framework as applies to consumable products generally.

Marketing of the purported medical, nutritional or health benefits of a consumable product in the UK is regulated by transposed EU law and the MHRA, which issues strict and very prescriptive guidance as to what may and may not be said; this therefore applies to wellness products containing CBD, or other cannabinoids.

As with other products, general product claims on CBD products are covered by the Consumer Products and Unfair Trading Regulations 2008 (CPUTR 2008).

“Novel food” rules also apply. The Novel Foods Regulation ((EU) 2015/2283) (NFR) defines a “novel food” as a food that was not consumed by humans to a significant degree within the EU before 15 May 1997.

The NFR requires that novel foods be authorised at European Community level, and provides an authorisation procedure by way of keeping a “Union List” (better known as the Novel Foods Catalogue). In January 2019, it was decided that the NFR reference to Cannabis sativa L should be extended to include the entry of cannabinoids. Therefore, any cannabis extract intended for consumption would be considered a novel food and require authorisation before it can be sold. Only hemp seed oil extracted using traditional cold compression methods have the potential to be considered not novel by the FSA and, consequently, authorisation may not be required for all hemp seed products.

In England and Wales, the Food Standards Agency (FSA) regulates the food market. With the end of the Brexit transition period, the FSA opened its doors on 1 January 2021 to receiving NFR applications for food products intended for sale in England and Wales.

In England and Wales, CBD products had previously been sold without novel foods authorisation; accordingly, in February 2020 the FSA offered forbearance to businesses that were selling products on or before 13 February 2020. Those businesses that had a novel foods application submitted by 31 March 2021 and that were duly “validated” were allowed to continue to sell their products while awaiting full authorisation. No other products are allowed to be sold until they obtain full authorisation.

“Validation” is effectively an administrative check that involves establishing that an application contains all information required by law to allow it to proceed to the authorisation process. The quality of the data is not assessed at this stage, and if any of this information is missing, the application cannot be legally validated.

The forbearance position was made clear by the FSA on 11 March 2021, when it announced that applications no longer needed to be “validated” but just “submitted” by 31 March 2021. The FSA press release stated:

“The criteria for products which can remain on sale from 1 April 2021 has been updated. Previously, only products that were on sale at the time of the FSA’s announcement (13 February 2020) and that were linked to an application which had been validated by 31 March 2021 were to be included. To maximise the opportunity to pass validation, this now includes all products on sale on 13 February 2020 and linked to an application submitted before 31 March 2021 that is subsequently validated.”

On 19 April 2021, the FSA produced a list of 43 CBD food products on sale in England and Wales that were allowed to stay on the market until a decision on their authorisation had been made (as they had met the requisite validation threshold). The list produced by the FSA is split into two sections, which comprise products associated with applications that either:

• have been validated in the initial stage of the process before going on to the safety assessment; or
• are “on hold”, with applicants who have set out robust plans to complete the risk assessment but who are yet to supply all the information needed to continue in the process.

The list saw several updates from early 2022, with around 6,000 products showing by the end of April. At this stage, the FSA also began striking products from the list, and to date 409 have been removed following further review of their applications, as they did not pass the pre-validation stage. On 30 June 2022, it was confirmed that no more products would be added to the list on the basis of the forbearance position, and new products would need to be fully authorised before they can be added to the list.

As of early-2024, there are 12,115 products on the list, and all are either showing a validated status or are on hold awaiting evidence. The FSA recently noted that the first of these applications is not expected to be fully authorised until Summer 2024 at the earliest.

Cosmetics

The primary legislation concerning cosmetics is Regulation (EC) No 1223/2009 (the “EU Cosmetics Regulation”) and Schedule 34 of the Product Safety and Metrology, etc (Amendment, etc) (EU Exit) Regulations 2019. The regulations do not prohibit CBD ingredients in cosmetic products other than CBD that is extracted from the buds or “flowering tops”.

Following the European Court of Justice (ECJ) decision in Kanavape (which ruled that precluding a product from a market based on the part of the cannabis plant used for extraction was unlawful) the cosmetic ingredients database (CosIng) was updated, and as of 2 February 2021 CBD had been added. CosIng is the EU’s official database for cosmetic ingredients – it is not applicable to the UK following Brexit, but the Kanavape ruling is binding on UK courts and, as such, companies extracting CBD from the buds of cannabis plants should no longer face enforcement.

Again, as with food products, since the Brexit transition came to an end, the Office for Product Safety and Standards (OPSS) handles the listing of cosmetic products in the UK.

Vaping products

The vaping sector is regulated by the Tobacco and Related Products Regulations 2016 (TRPR). CBD products are not captured by the definition of “herbal product for smoking” pursuant to Part 5 of the TRPR. Part 6 on e-cigarettes will only apply where there is some sort of tobacco-derived material contained within the product. If the proposed CBD products contain no tobacco-derived material (eg, nicotine), they will not be caught by these regulations.

Industrial hemp

The cultivation of hemp is an augmenting industry in the UK: the leaves and flowers of the hemp plant – cannabis plants with notably low tetrahydrocannabinol (THC) content – remain classified as Class B controlled substances under the MDA 1971. However, the MDR 2001 permits the cultivation and certain handling of the hemp plant subject to a licence with special conditions attached, obtained through the Home Office (see 1.2 Regulatory Bodies). As hemp is typically grown for the industrial application of fibres and the nutritional benefit of its seeds, the licences granted for its cultivation usually require the destruction of the leaves and flowering tops on the growing site. A Controlled Drugs Licence would need to be obtained from the Home Office in order to handle the parts of the plant controlled by the MDA 1971.

The MHRA Regime for Medicinal Products

Licensed cannabis medicines

Prior to the change in law in 2018, only three cannabis medicines could be prescribed in the UK: Sativex, Epidyolex and Nabilone. The reason that these products could be prescribed despite the criminalisation and “Schedule 1” restriction of cannabis in the UK was because they are licensed medicines. This is to say that these medicines had been through clinical trials, received marketing authorisations from the MHRA and been individually rescheduled out of Schedule 1 of the MDR 2001 into less restrictive schedules as part of their MHRA licences.

In addition to controlled drugs legislation, the laws applicable to these types of cannabis medicines are those that apply to general pharmaceuticals – ie, the MHRA’s regime for licensed medicinal products, encompassing everything from investigational medicinal product rules and clinical trials legislation to marketing authorisation requirements and the pharmacovigilance regime.

Treatment with these licenced cannabis medicines can be funded by the NHS, but only for a very small number of indications. For individuals suffering from indications other than those for which the three licensed cannabis medicines were approved, there was no option in the UK in terms of cannabis medicine pre-2018.

Unlicensed cannabis medicines (CBPMs)

The change in law in 2018, however, meant that CBPMs – cannabis medicines that did not have a marketing authorisation (or “licence”) – could now be prescribed by specialist doctors. With an estimated 1.4 million citizens in the UK obtaining cannabis for medical use from the legacy market, private companies flocked to the industry to meet the anticipated demand for CBPMs. 20 to 30 private clinics regulated by the Care Quality Commission have since set up operations in the UK and started prescribing, which, as noted above, has allowed private prescription of CBPMs to increase tenfold from 2020 to 2021, and then to double from 2021 to 2022. The law relating to CBPMs stems from:

• regulatory rules and guidance that apply to unlicensed medicines (for example, the Human Medicines Regulations 2012, and MHRA guidance that stipulates particulars around the manufacture, distribution, labelling, storage, marketing, importation and exportation of CBPMs);
• regulated participants in the medicine or patient care chain (for example, CQC rules for clinics and GPhC rules for pharmacies); and
• licensing rules and quality guidelines applicable to the supply chain (for example, cultivation (GACP), distribution (GDP) and manufacture (GMP)).

Curiously, the MHRA has not yet allowed exports of CBPMs to countries outside the UK – a restriction that is puzzling to many considering the enormous potential investment, tax and domestic cost-efficiency benefits (not to mention the fact that the UK has been hailed as the world’s largest exporter of (non-CBPM) cannabis).

Regulatory Authorities

Medical cannabis and cannabinoids, and their uses, are regulated by a number of authorities, depending on the sector in which they are used. Below is the relevant regulatory authority for each sector, and its scope.

The Care Quality Commission (CQC)

The CQC regulates health and social care in England.

Private clinics prescribing CBPMs and licensed cannabis medicines must undergo monitoring and inspection by the CQC.

While there are no cannabis-specific elements of CQC regulation that apply to clinics prescribing cannabis medicines, it is necessary to be aware of the requirements of the inspection regime.

The Food Standards Agency (FSA)

The FSA regulates and oversees the food industry in the UK. It is responsible for maintaining food safety and hygiene, with power to enforce through local Trading Standards, if needed.

Ingestible CBD is categorised as a “food supplement” in the UK, and therefore these types of products are regulated by the FSA.

Echoing the view of the EFSA (its European counterpart), the FSA holds the opinion that CBD is a novel food and therefore requires that producers of CBD and the resulting ingestible products be subject to an application procedure to ensure safety and standardisation.

The Medicines and Healthcare products Regulatory Agency (MHRA)

The MHRA is responsible for overseeing medicines and certain healthcare products in the UK market.

The MHRA is responsible for assessing and ensuring the safety of medicinal products and medical devices that are already on, or are to be placed on, the UK market.

The MHRA’s duties in relation to CBD extend to monitoring the extent that the cannabinoid is not being marketed as a medicinal product without the proper safety, quality and efficacy tests being carried out as part of marketing authorisation approval.

The National Institute for Health and Care Excellence (NICE)

NICE publishes guidance on the use of new and existing medicines, treatments and procedures, as well as on clinical practice.

NICE’s guidance dictates whether, and how, particular medicines are prescribed through the NHS, particularly with regard to cost justification and the indications that a drug should be used to treat.

NICE’s guidelines on the use of cannabis medicines currently restrict the indications that it can be used for, and this is one of the key reasons why their prescription is not more widespread in the NHS.

The Home Office

The Home Office operates as the UK National Cannabis Agency (pursuant to the UN Single Convention on Narcotic Drugs 1961).

The Home Office acts in a regulatory capacity with respect to cultivation licensing and other cannabis-related activities, and oversees the issuance and maintenance of both hemp and high-THC controlled drugs licences.

The Home Office also acts through Border Force with respect to inspecting imports and exports, and will seize cannabis and CBD-related products that it suspects do not comply with national legal requirements.

The Veterinary Medicines Directorate (VMD)

The VMD is primarily responsible for protecting animal (and pet) health.

The VMD views CBD as a medicine when given to animals, thus requiring a rigid scientific assessment and application procedure (plus approval) for a CBD product for pets to be placed on the UK market.

The VMD has restricted access to the UK market for CBD treats or products for pets without proper authorisation, and can enforce its decisions.

Advisory Authorities

The Advisory Council on the Misuse of Drugs (ACMD)

The ACMD is an advisory, rather than regulatory, body and makes recommendations to the government on the control of drugs that may be dangerous or otherwise harmful, including classification and scheduling under the MDA 1971 and its regulations.

In January 2021, the ACMD was commissioned to advise the government on establishing a legal framework for consumer CBD products. On 20 December 2021, the ACMD provided a report that contained conclusions as a result of key research undertaken, and four recommendations for the government. The four recommendations were as follows.

• The total dose of trans-delta-9-tetrahydrocannabinol-C5 (delta-9-THC) and all other controlled phytocannabinoids in consumer CBD products should be controlled. The dose of each controlled phytocannabinoid should not exceed 50 micrograms per unit of consumption.
• Regulatory authorities should ensure compliance with the above – this recommendation infers regulatory co-operation (for example, between the Home Office, FSA, OPSS, DHSC and DEFRA, the report notes).
• A further inter-laboratory comparison trial (“ring trial”) should be commissioned, specifically to support the capability of testing laboratories to detect controlled phytocannabinoids below the recommended maximum levels in a representative range of consumer CBD products.
• The development of more accurate testing for controlled phytocannabinoids should be supported, to allow testing capabilities to develop and be fully regulated.

The government responded to the ACMD’s recommendations on 21 January 2022, agreeing with the purpose of each of the four recommendations, though noting that it believed some of the proposed outcomes could be delivered in a different way.

A number of trade bodies at the UK and EU level represent companies in the cannabinoid wellness industry, and provide guidance and referrals for those wishing to enter the industry. They usually provide an annual membership, which requires members to have their products routinely tested for safety and efficacy, and to ensure that they are of a high standard and not misrepresenting the cannabinoid content.

Public and Professional Unfamiliarity

By far one of the biggest struggles for market participants in the medical cannabis and cannabinoid wellness sectors is the lack of reliable information for consumers and the lack of education for clinicians or support by medical bodies such as NICE, the MHRA and the NHS.

Part of the confusion may lie in the unique and complex properties of the cannabis plant itself: a historically well-known but poorly understood plant comprising a blend of hundreds of different extractable components – some psychoactive and others not, some expressly controlled and others controlled to varying degrees, some with applications for wellness or for medicine depending on the precise dose and form, and many unstudied altogether.

The non-criminally controlled cannabinoid CBD has been shown to have medicinal properties not dissimilar to licensed medicines already in the market, yet CBD product producers are restricted from marketing non-licensed CBD products as having medicinal properties. The challenges here are inherent to the plant and to the law, and it is no surprise that educational difficulties are at the top of that list.

Pace of Change

Legal change in relation to the cannabis plant is happening at two different levels:

• at the macro-level (major national change, generally implemented through amendments to primary legislation); and
• at the micro-level (more granular, technical changes, usually to regulatory rules or guidance, for example).

The pace of change at the macro-level is slow – for example, making cannabis-based medicines available to the UK public. Any changes at this level are a protracted exercise, not only because amending legislation is an onerous task involving many different working parts, but also due to politics. A further complication arises as UK and EU legislation in this area is interlinked with international law (ie, the UN Conventions), which adds another layer of complexity to the amendment process.

The pace of change at the micro-level is relatively fast. This generally involves targeted tweaks to regulations and guidance that address how specific elements of the cannabis plant are treated in England and Wales. These changes are more numerous and less red tape is involved in the amendment process, so changes can be realised more quickly. Changes might include:

• changes to the percentage of THC allowed in a cultivar;
• changes to novel food rules; or
• updates to the CosIng database.

Strict Laws and Expensive/Protracted Licensing

The current rules, particularly around licensing, create substantial bottlenecks that prevent the UK industry from operating at full capacity.

For example, the threshold for permissible THC levels in products or containers is not expressed as a percentage, but instead as a fixed milligram measure. This means that manufacturers cannot import or possess the bulk CBD distillate required to create their products (without an expensive and difficult-to-obtain licence), even though no controlled drugs licence is needed for the possession or sale of the CBD products themselves. Even this permissible threshold was, for a long time, untested regarding its applicability to the commercial CBD market, and it was only in early-2024 that the judicial review of a decision to ban the exportation of CBD products from Jersey to the UK confirmed that a permitted de minimis amount of THC is allowed in CBD products provided they meet certain criteria.

Another example is the outdated controlled drugs licensing system itself. Both the licence required to cultivate cannabis and the licence required to permit the possession of controlled cannabinoids (that may arise as a result of the manufacturing process) require applicants to spend (some would say) disproportionate time and money in meeting Home Office licence requirements. The administrative difficulties of achieving approval have also come under criticism: the protracted application process can take two years, even when unsuccessful.

Without a licence, extraction of CBD is also only permitted from the CBD-sparse stalks and seeds of the plant, making commercial extraction almost impossible and creating yet another CBD-sourcing issue; and the MHRA does not allow exportation of UK-produced CBPMs, substantially restricting investment into the UK market.

Resolving these systemic licensing issues would increase the efficiency and profitability of the UK’s commercial sector, and alleviate barriers to medical research.

Regulatory Uncertainty

The current regulatory regime is underdeveloped, fragmented and product-dependent.

No overarching regulatory regime has been developed for the plant and its component parts. For this reason, a legal grey area exists over many aspects of cannabis use. The patchwork of regulations across various sectors is open to misinterpretation and confusion – for example, the common misunderstanding that it is legal to sell and consume hemp flower/buds in the UK. Unexpected interpretations of existing legislation and regulations have also led to serious legal consequences for producers and commercial enterprises, particularly in the CBD sector.

The one area where there is relative simplicity and clarity is licensed cannabis medicines, where the regulatory regime is the same as for other medicines in the UK.

Changing Regulations

One major risk area for companies is the unstable regulatory regimes governing cannabis and cannabinoids in the UK. This has never been more relevant than in the post-Brexit landscape. With the opportunity to garner more autonomy in terms of how cannabis is treated – and particularly in relation to CBD – the UK may steer away from the existing regulations to better achieve its own ambitions for the cannabinoid.

The FSA has already shown a willingness to take a different view to the EU (for example, on the topic of CBD being classified as a narcotic or a food – to which the ECJ eventually decided in favour of the latter, as was the FSA’s stance). An example such as this – but with a different result – could dramatically shift how enterprises work in the UK.

Given the rapid public adoption of legal cannabis-derived products, particularly CBPMs and CBD, there may come a time when the government introduces cannabis-specific legislation. Participants in the cannabis sector should closely follow industry developments.

Unclear, Unpublished, Untested and Generic Regulations

Some sources of legislation that govern cannabis were drafted in the early-1960s and the 1970s. Aside from considering them outdated in many respects, observers note that these laws are unfit for purpose, as they were put in place to control the criminal trading of the plant, rather than to govern a commercial industry. For this reason, some of the central rules on which the industry relies are unclear and have not been tested in the courts. As a result, confusion was rife in the industry for years, with many participants relying on inapplicable thresholds and a general lack of consensus as to many of the rules. The situation has broadly improved following regulatory guidance, a handful of rulings and growing industry awareness of the law, but there is still a long way to go.

Another example of underdeveloped regulation is the current rules on which the CBPM market relies – these are the generic rules that apply to all unlicensed medicines. Participants in the medical cannabis industry note that these rules are not sufficiently bespoke, particularly around importation and distribution, to cater for the current needs of patients and the industry participants that support them. The industry reports a range of issues as a result, including products constantly going out of stock, products expiring before reaching patients and other continuity-of-care issues.

Another challenge is the haze that sits between the industry and regulators owing to the body of internal expectations, rules and processes that remain largely unpublished. Regulators are regularly asked to confirm their expectations with regard to licensing requirements, operational procedure, quality requirements and which particular guidelines apply to certain parts of the seed-to-shelf process. Some regulators have been praised for their understanding and co-operative approach with current and prospective licence holders in light of these difficulties.

Proximity to Criminal Liability

Lawful activity in the cannabis industry sits close to the national criminal law regime. The only element separating lawful business and illegal activity is either an appropriate licence (covering manufacture, possession, supply, importation or exportation, for example) or adequate legal advice (covering which parts of the plant are lawful to use or extract from without a licence, for example).

The Proceeds of Crime Act

Part 7 of the Proceeds of Crime Act 2002 (PoCA) criminalises dealing with or entering into arrangements in respect of the proceeds of “criminal conduct”. The definition of criminal conduct in the PoCA captures conduct which is lawful overseas but which would be a crime if it occurred in the UK.

Certain risks may arise for investors, and professional services firms in particular, where funds are received from overseas companies that have generated their revenues from sources that are not yet lawful in the UK (recreational cannabis, for example). Best practice should always be followed. This issue is not a straightforward one, with no clear authority on certain matters that arise.

UK Criminal Law

In terms of the MDA 1971, possession, supply or importation of a Class B controlled substance are “either-way offences” (ie, criminal offences that can be heard in the Magistrates’ Court or Crown Court). Charges are brought by the police on the advice of the Crown Prosecution Service (CPS), which then conducts the prosecution case in court. The maximum sentence on indictment for possession of a Class B substance is five years’ imprisonment (or an unlimited fine). For offences of supplying a drug of Class B, the maximum sentence is ten years’ imprisonment (or an unlimited fine).

For an offence of importing (or exporting) a drug of Class B, the maximum sentence is 14 years’ imprisonment (or an unlimited fine). The CPS may elect to charge the business that sells the product or the individuals involved in importing, storing or selling the product.

Section 28 of the MDA 1971 provides a defence where the accused neither knew nor suspected that the substance in question was a controlled drug. Per the judgment in R v Lambert [2001] UKHL 37, the burden is on the prosecution to disprove this defence, once raised by the accused, beyond reasonable doubt.

It should be noted that offences of conspiracy to supply or import a controlled substance are not subject to this statutory defence, as they are strictly speaking offences under the Criminal Law Act 1977.

Packaging and Labelling Law

In general, putting misleading claims on products is an offence under Regulation 9 of the CPUTR 2008. It is punishable by either a fine or two years’ imprisonment.

As previously mentioned, the MHRA regulates the area of medicinal products. In practice, as long as products do not make the medicinal claims or present themselves as medicines, the MHRA has been reluctant to intervene and require authorisation. Breaches of the marketing authorisation requirement are punishable by either a fine or two years’ imprisonment.

The UK Advertising Standards Agency (ASA) will act against businesses breaching any of the rules regarding unauthorised health claims made in marketing materials about food products. Local Trading Standards are empowered to enforce law and regulation when it comes to food labelling. Breaches here are punishable by either a fine or two years’ imprisonment. Making general or specific health claims about CBD is unauthorised.

The UK’s Border Force also acts as an enforcement authority and will seize products that are suspected of breaching national laws. This is not limited to criminal law, but also applies to food law and other regulations.

There is no harmonised international regulatory landscape that clearly sets out the rules for the activities of cannabis and cannabinoids. This has left a variety of jurisdiction-specific rules – eg, permitted levels of THC in CBD products.

The EU is progressing towards a more harmonised set of laws to maintain consistency in the industry, and this was demonstrated in the Kanavape case of November 2020 (the Court of Justice of the European Union (CJEU) case number C-663/18), where the CJEU clarified that the principles of EU law supersede those at member state/national level, regardless of the product or interest in question.

The CJEU went one step further in its decision by announcing that, based on the available safety and scientific evidence, CBD cannot be classified as a narcotic, especially in light of the 2020 UN decision (see below) – in particular noting that CBD’s apparent non-psychotropic effect and lack of any harmful effect on human health goes against the spirit of the Single Convention on Narcotic Drugs 1961, which was drafted for protection against harmful and damaging drugs.

As a result, the European Commission has publicly announced that CBD should not be treated or regulated as a narcotic, and that CBD should qualify as a food (albeit a novel food), paving the way for a route to market through novel food authorisation.

This could provide a benefit for the UK: a consistent approach to treatment of cannabinoids and their production will go a long way towards easing cross-border trade. At present, however, it is worth noting that CBD novel food applications in the EU were placed on hold as the European Commission consults the European Food Safety Authority (EFSA) to give its opinion on the safety of CBD consumption for humans. In June 2022, the EFSA issued a statement identifying a number of data gaps with the health effects of CBD intake, requiring evaluation before it can make a determination. See Cannabidiol novel food evaluations on hold pending new data – EFSA (europa.eu).

The German government’s decision to create an adult-use market in the country will also have further ramifications for the development of cannabis regulation on the continent, and by extension in the UK, although it is hard to predict whether there will be the political will in the UK to align with any developments in the regulatory regime in the EU and mainland Europe. Watch this space carefully.

UN CND Decision

On 2 December 2020, the United Nations’ Commission on Narcotic Drugs (CND) held a vote that resulted in the removal of “cannabis and cannabis resin” from Schedule IV of the Convention (reserved for the most harmful narcotic substances). This is expected to alleviate issues with access and availability of cannabis for medical and scientific purposes at national level. However, this is not expected to affect the CBD industry, as “extracts […] of cannabis” were left in Schedule 1, allowing the legal controversy around CBD extracts to continue.

Furthermore, the CND rejected a proposal for a note to accompany the Schedules clarifying that preparations that contain predominantly CBD and less than 0.2% THC should not fall under international control. While the CND recognises cannabis as having a beneficial medical application, as far as recreational and wellness use is concerned, reluctance to relinquish full control remains.

Access to medical cannabis is currently limited by a number of legal and policy factors.

The greatest (legal) access barrier is that medical cannabis in the UK cannot initially be prescribed by general practitioners, per se. The statutory instrument that rescheduled cannabis in the UK included a provision that restricted the prescribing of cannabis-based medicines to those doctors who were specialists in an area of concern (eg, paediatrics, ophthalmology, etc) and listed on the GMC’s Specialist Register. Less than 30% of the UK’s doctors are on this register and, in practical terms, only a fraction of these specialists could be in a position to prescribe medical cannabis to patients, thereby creating a considerable bottleneck in meeting patient need. There is a prospect of the prescription bottleneck being eased somewhat, with the UK Home Office acknowledging that e-prescribing should be made possible for CBPMs, but no changes to the rules have yet been made.

A second element affecting access to medical cannabis is guidance issued by NICE. This guidance, which ultimately affects state-funded access to medical cannabis, recommends the medicine for only four indications:

• chemotherapy-induced nausea and vomiting;
• spasticity in adults with multiple sclerosis;
• severe treatment-resistant epilepsy; and
• tuberous sclerosis complex.

It has also been suggested that guidance from the British Paediatric Neurology Association (BPNA) is restrictive (whether duly or unduly) and affecting patient access.

As a consequence of Brexit, reduced import and export flexibility has reportedly affected access to some cannabis-based products for medicinal use (CBPMs) in the UK.

As described in 1.1 Primary Law & Regulations, cannabinoids are caught by the Novel Foods Regulation, as there is no evidence of their consumption by humans to a significant degree (as extracted or purified) within the EU before 15 May 1997.

This means that products or foods containing any cannabinoids will require full authorisation prior to being used in foods. However, in the UK companies may continue to market their products in England and Wales if they were on sale on or before 13 February 2021 and if a novel foods application was submitted by 31 March 2021 and was subsequently validated.

There is no doubt that “decriminalisation” and “recreational regulation” are words constantly on the lips of everyone in every level of this sector. The discussion papers that have been presented suggesting the socio-economic benefits of the plant – spanning medicinal, industrial and economic factors – keep the fires of discussion alight.

That said, to date there have been no formal moves by the government to decriminalise, regulate or legalise cannabis for recreational purposes. However, small but significant attitude changes may be observed from politicians and state institutions, involving a number of debates in Parliament (for example, Sir Norman Lamb’s December 2018 motion to legalise the possession and consumption of cannabis), and there has been a subtle but profound relaxation in terms of charging those who are in possession of small amounts of cannabis for their own personal use.

In 2019, a cross-party group of MPs went on a fact-finding trip to Canada to experience how a legal and regulated cannabis market operates. In the context of the 2021 London mayoral candidate race, the incumbent Mayor of London, Sadiq Khan, stated that he would consider looking into the partial decriminalisation of cannabis in the capital. Khan subsequently launched the London Drugs Commission to examine the effects of drug policies, announcing it in May 2022. The hostile reception from the Labour Party to the idea of a relaxation of cannabis laws suggests that political appetite for following Germany in exploring an adult-use market is limited, and at the end of 2023 Khan announced that the Commission had been put on the back-burner.

As far as users of cannabis for bone fide medical reasons are concerned, there is an initiative in the UK that aims to help these users avoid criminal consequences of cannabis use. The card scheme is a non-government initiative that is publicly supported by members of parliament, a number of national and local police associations, and other bodies. The initiative provides members with a card confirming that the holder has been diagnosed with a condition that cannabis has been shown to treat. It does not provide a defence to possession in law, but aims to support a police officer’s use of discretion during a search or arrest, with the hope (and, in most cases, result) that the user will not face criminal sanctions for possession.