Recently, three British MPs went to Canada on a fact-finding cross-party trip to consider the effects of a more relaxed regulatory environment in respect of cannabis. After the trip, the MPs predicted that the UK would follow Canada’s lead and legalise cannabis for adult use within a decade.
The recent trend towards decriminalization of cannabis in other countries suggests they may be right, but in the meantime, a proliferation of products containing extracts from cannabis plants are appearing in UK stores. This Client Alert sets out the current rules regarding the regulation of cannabis products and medicinal cannabis in the UK.
What substances are at issue?
Cannabinoids are the chemical substances found in cannabis. Over 100 different cannabinoids have been linked to the cannabis plant. The two that are most relevant to the ongoing medical and legalisation debate are cannabidiol (CBD) and tetrahydrocannabinol (THC). The key difference between CBD and THC is that THC has psychoactive properties, meaning users experience a high from its use, whereas CBD has no psychoactive properties (it contains little or no THC).
What is the relevant legislation?
The main relevant UK legislation is the Misuse of Drugs Act 1971 (the Act) and the Misuse of Drugs Regulations 2001 (as amended by the Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland) Regulations 2018) (the Regulations).
In the UK cannabis, cannabinol and cannabinol derivatives are classified as Class B drugs under Schedule 2 of the Act; as such, they are controlled drugs. Cannabinol derivatives include tetrahydro derivatives. THC, a tetrahydro derivative of cannabinol, is a controlled drug under the Act. CBD is not listed in any schedule of the Act and so is not, of itself, a controlled drug.
The Regulations set out how controlled drugs can be used legally for legitimate purposes and the various restrictions on import, export, production, possession and supply that apply, as well as the different labelling, record-keeping, destruction and safety requirements that are applicable based on the schedule to the Regulations that governs the controlled drug. Cannabis, cannabinol and cannabinol derivatives are included in Schedule 1 of the Regulations; therefore, they are subject to Schedule 1 restrictions. CBD is not listed in any of the schedules of the Regulations, so it is not controlled by the Regulations.
After a review of cannabis regulation in the UK announced by the Home Secretary last year (prompted by the cases of two children who had been denied access to cannabis oil to control their epileptic seizures), the Regulations were amended in November, 2018 to create a new category of generally unlicensed cannabis-based products – called “cannabis-based product for medicinal use in humans” (CBPM) in order to allow unlicensed cannabis-based products to be prescribed for medicinal purposes, provided certain requirements are met.
Restrictions and licensing requirements
In order to legally produce, possess, supply, cultivate, import or export cannabis products, there are various regulatory requirements that must be met, depending on whether the product contains a controlled drug or is classified as a CBPM. It is important to remember that even if the end product is an exempt product or a CBPM, it is still an offence under the Act to cultivate the cannabis plant without a Home Office cultivation licence, which will be granted only if certain conditions are met.
Because THC is a controlled drug, products that contain THC are subject to strict legislative controls. For example, section 3(1) of the Act prohibits the importation and exportation of controlled drugs; section 4(1) makes it unlawful to produce, supply or offer to supply a controlled drug; and section 5(1) makes it unlawful to be in possession of a controlled drug. The Regulations provide that the restrictions in the Act on importation, exportation, production, supply and possession do not apply to substances that qualify as “exempt products”. Under the Regulations, an “exempt product” is a preparation or other product containing a controlled drug where “(a) the preparation or other product is not designed for administration of the controlled drug to a human being or animal; (b) the controlled drug in any component part is packaged in such a form, or in combination with other active or inert substances in such a manner, that it cannot be recovered by readily applicable means or in a yield which constitutes a risk to health; and (c) no one component part of the product or preparation contains more than one milligram of the controlled drug…”. The meaning of “exempt product” is not wholly clear, but the Advisory Council on the Misuse of Drugs, a public advisory body, suggests that the exempt product definition is intended to relate to small quantities of controlled substances which are in a non-recoverable form and are not for human [or animal] administration. The exempt product exception is therefore likely to have limited applicability to products containing THC that are currently being sold in UK shops.
Pure CBD is not a controlled drug under the Act or the Regulations. However, the Home Office’s position appears to be that it is very difficult to isolate pure CBD and remove any controlled cannabinoids, such as THC (despite the fact that there are producers who unequivocally say they can do so) and the presence of THC (even in very small quantities) is highly likely to mean that CBD products intended for human or animal administration are controlled under both the Act and the Regulations. Thus, the Home Office’s approach seems to be that a Home Office licence would be required to import, export, produce, supply or possess CBD products. Nevertheless, products advertised as containing CBD are widely available in the UK, and there is disagreement as to whether the position taken by the Home Office is correct. It has been reported that the president and chief scientist of the Royal Pharmaceutical Society have written to the Home Office asking it to provide clear guidance on the steps that pharmacists should be taking to ensure that they abide by the law in respect of CBD oils, in light of reports that have been circulating suggesting that CBD oil products with a THC content of less than 0.2% are legal and by implication that they may not require a Home Office licence (these reports may be based on the interpretation of the regulations relating to the cultivation and importation of low THC industrial hemp).
Even if a CBD-containing product is not subject to the controls of the Act or the Regulations, the UK’s medicines and medical devices regulator, the Medicines & Healthcare products Regulatory Agency (MHRA), has taken the view that “products containing cannabidiol (CBD) used for medical purposes are a medicine” and as such must have an MHRA product licence (marketing authorisation) before being made available to consumers, supplied or advertised unless they fall under the narrow exemptions of the Human Medicines Regulations 2012 (the exemptions now include CBPMs, subject to certain controls). To date, only one cannabis-based medicinal product, Sativex, (for the treatment of multiple sclerosis) has been licensed by the MHRA.
The Regulations define a CBPM as a preparation or product that
(a) is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers);
(b) is produced for medicinal use in humans; and
(i) a medicinal product, or
(ii) a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product[.]
A limited number of substances are excepted from the definition, including Sativex (as a licensed product) and synthetic dronabinol. Only if a cannabis product meets the requirements above will it be considered a CBPM – otherwise, it will be treated as a Schedule 1 drug under the Regulations; that is, a drug that has no known legitimate medical uses and that can generally be used only for research under a Home Office licence.
While allowing unlicensed cannabis-based products to be prescribed for medicinal purposes, the recent amendments to the Regulations set out restrictions relating to the supply of CBPMs. Where CBPMs are unlicensed i.e. they have not obtained a marketing authorisation from the MHRA, a prescription for a CBPM can be written only by a specialist doctor on the General Medical Council’s Specialist Register and in accordance with the regulations applying to “special medicinal products”. If a CBPM receives a marketing authorisation from the MHRA, it will cease to be a “special medicinal product” and can be prescribed by other qualified practitioners.
Further, entities in the CBPM’s supply chain must be licensed by the Home Office and MHRA. For example, importers must have a Home Office import and domestic licence and manufacturers must have a domestic licence and an MHRA dealer’s or manufacturer’s licence to supply and possess CBPMs. Wholesale distributors must also be licensed. Cultivation of cannabis also requires a Home Office licence. In addition, there are import notifications, records, storage and labelling requirements with which importers, manufacturers and wholesalers must comply. Doctors prescribing CBPMs need to be confident that the actual supply of the CBPM they prescribe is lawful.
In addition, CBPMs can be prescribed by doctors only when there is clear published evidence of benefit or UK Guidelines (which have not yet been published), and only to patients whose established treatment options have been exhausted.
The public health minister said that as of May 2019, only six NHS prescriptions had been written since the changes to the Regulations came into effect and ten private prescriptions were written between January 2019 and February 2019 according to the NHS Business Services Authority, which collects data on primary care. No data is available regarding prescriptions written in respect of secondary care.
Novel Foods Regulation
EU Regulation 2015/2283 of the European Union (the Novel Foods Regulation) regulates “novel foods”. A novel food is “any food that was not used for human consumption to a significant degree within the Union before 15 May 1997”. Under EU law, in the interests of safeguarding public health, novel foods must undergo a safety assessment before they can be authorised for placing on the market. On 17 January 2019, a new entry for cannabinoids was added to the Novel Food Catalogue (a non-legally binding guide in which the EU makes recommendations to member states as to whether a product is likely to require authorisation under the Novel Foods Regulation). The entry provides that “products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated”. However, seeds, seed oil, hemp seed flour and defatted hemp seed are not deemed to be novel foods unless cannabinoids have been added to them.
It is now up to EU member states to determine whether CBD products require authorisation in order to be marketed in the relevant member state. However, member states are often influenced by the fact that a food has been listed in the Novel Food Catalogue, so it seems likely that many products will now be treated as novel foods that require authorisation. The Food Standards Agency, the UK’s regulatory body in charge of food safety, has said that it accepts the EU’s clarification that CBD extracts are novel foods and that it is “committed to finding a proportionate way forward by working with local authorities, businesses and consumers to clarify how to achieve compliance in a marketplace in a proportionate manner”. Accordingly, in England, local authorities will have the power under the Novel Foods (England) Regulations 2018 to seize and inspect suspected unauthorised novel foods and issue compliance and stop notices requiring a product to be removed from sale – for instance, when there is reason to suspect it could be harmful to consumers – and to impose fines. The European Food Standards Agency, which is responsible for food safety in the European Union, is currently considering the first novel food application for CBD.