Cannabis law and legislation in the UK

It is in principle lawful to produce, supply, offer to supply, import, export, have in possession or cultivate (in the case of the plant) cannabis products, including medicinal products, when done under a relevant licence issued by the UK Home Office.

Subject to conditions prescribed in statute, products falling within the statutory definition of cannabis- based products for medicinal use in humans may be ordered for and/or supplied to patients, and possessed by the patient, without the patient or the supplying healthcare practitioner requiring a licence from the UK Home Office (though a licence is required for all possession and supply in the supply chain up to the healthcare practitioner). Certain other cannabis products are specifically excluded from the definition of cannabis-based products for medicinal use in humans but may also be lawfully supplied in the UK.

Despite allowing supply to patients without a Home Office licence for medicinal use, the legislation maintains safeguards for patients by specifying that cannabis-based products for medicinal use in humans may only be lawfully supplied in specified circumstances. The cannabis-based medicinal product must either be: (i) a medicinal product with a marketing authorisation under applicable medicines legislation; (ii) an investigational medicinal product supplied for use in the course of a clinical trial; or (iii) if an unlicensed medicine not supplied in the course of a clinical trial, a so-called ‘special’ meeting the requirements for ‘specials’ set out in the Human Medicines Regulations 2012 and supplied in accordance with a prescription by a specialist doctor.

Note that it is unlawful to self-administer a cannabis- based product for medicinal use by way of smoking (other than for certain research purposes).

As to potential criminal sanctions for breach of the statutory requirements: (i) possession can be punished with imprisonment up to five years, an unlimited fine or both; (ii) supply and production can be punished with imprisonment up to 14 years, an unlimited fine or both; and (iii) manufacturing or selling by way of wholesale a medicinal product without a valid manufacturing or wholesale distribution licence, and selling or possessing for sale an unauthorised medicinal product can be punished with imprisonment up to two years, an unlimited fine or both.

Subject to the limited medicinal supply referred to above, in general, use of cannabis is only lawful under the Misuse of Drugs Act 1971 when specifically authorised under a Home Office licence. To date Home Office policy has remained to not issue licences permitting recreational use.

Hemp may be lawfully cultivated and processed for industrial use under a so-called ‘Industrial Hemp’ licence issued by the Home Office. The Home Office only issues licences for cultivation of hemp plants from approved seed types with a tetrahydrocannabinol (THC) content not exceeding 0.2%. The legally controlled parts of the plant (i.e. the leaves and flowers) cannot be used under an Industrial Hemp licence and must be destroyed.

Industrial hemp can be lawfully used for the commercial production of hemp fibre for industrial purposes and/or the obtaining of seeds which are then pressed for their oil, for use in cosmetics and food supplements, provided they do not contain more than trace THC. In the case of cosmetics only those parts of the plant permitted in the EU Retained Law for cosmetic purposes may be used.

Food products that contain Cannabidiol (CBD) extracts or isolates are classified as novel foods. This means that to be sold lawfully the product must have a ‘Novel Foods Approval’. Product sold in the EU requires a Novel Foods Approval considered by European Food Standards Agency (EFSA) and its "normal" process continues. However, as of 1 January 2021, separate new applications need to be made for CBD food product sold in the UK. Since that date The Food Standards Agency (FSA) now considers and approves novel foods applications for food sold in the UK. The requirement for EFSA approval has been subject to differing guidance in recent years but the FSA clarified that in the UK all CBD Food Products that had been on the UK market on 13 February 2020 must be the subject of a validated novel foods application for CBD product. The application should be submitted to the FSA by 31 March 2021 at the latest. The validated application will then be subject to a second stage approval process. The FSA will publish a positive list of products with validated applications, and any existing product without a submitted application will be at risk of product recall after 31 March 2021.

CBD is not a legally controlled cannabinoid in the UK so the possession and supply of pure CBD oil does not require a Home Office licence in the UK (though it may need to comply with other product regulation where supplied for particular purposes, e.g. novel food, food supplement or cosmetic products legislation).

In the UK, cannabis related products are potentially patentable including cannabinoid extracts, dried flowers, medical formulations and inhalation devices or systems. It may also be possible to obtain protection for cannabis plants in the United Kingdom in certain circumstances, although plants produced by essentially biological processes per se (in general, not specifically cannabis plants) are now not considered patentable by the European Patent Office, following an Enlarged Board of Appeal decision issued in 2020.. Plant variety rights are available to protect the plants.

Subsequent to the 1 November 2018 legislative changes which made it easier to prescribe and supply medicinal cannabis products in the UK, interim prescribing guidance was issued by healthcare practitioner professional bodies, including the General Medical Council guidance on prescribing unlicensed medicinal cannabis products, pending a consultation on clinical effectiveness of cannabis-based medicinal.

products by the National Institute for Health and Care Excellence (NICE). The NICE guideline was subsequently issued on 11 November 2019 providing guidance on prescribing of cannabis-based medicinal products for people with intractable nausea and vomiting, chronic pain, spasticity and severe treatment- resistant epilepsy. NICE is also developing technology appraisal guidance on cannabidiol with clobazam for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.

The NICE guidance follows the grant of a marketing authorisation for a second, non-synthetic medicinal cannabis product, GW Pharma’s Epidyolex, which has been licensed in the EU for Lennox-Gastaut syndrome and Dravet syndrome.

In January 2021, a second Home Office licence was granted to grow cannabis for commercial medical use. This is only the second licence of its kind to be granted, and will be a definite boost to the UK commercial cannabis market. On 11 January 2021, the UK government also consulted the Advisory Council on the Misuse of Drugs with a view to restricting the scope of ‘exempt products’ under the controlled drugs legislation whilst also creating a specific exemption in the legislation for CBD products that contain no more than a defined trace percentage of specified controlled cannabinoids, including THC to take account of the ability of producers to achieve such level of purity and the capability of forensic laboratories to quantify it consistently and affordably. This may indicate that the present UK government is generally supportive of the growing CBD market in the UK.