This report was published by CMS Law Firm.
In recent years cannabis trade and related activity has developed into a growth business area. In the life sciences and healthcare fields there have been increases in the numbers of patients having access to medicinal cannabis and more general acceptance of the potential medicinal value of cannabis for patients.The number of countries allowing its recreational use has increased. Additionally, there is growing awareness of the potential for and actual use of cannabis plants across a range of different industry sectors, not least in cosmetics and food.Taking account of the evolving political and ethical implications of cannabis production, trade and use it is important to be aware of differences in approach across different countries to assess which businesses and activities are viable in different (EU and non-EU) jurisdictions.This guide provides high level information about the legal approach to regulating cannabis across a variety of jurisdictions in different regions. In each case the guide focuses on (i) medical use; (ii) recreational use; (iii) industrial use and (iv) the patent-ability of cannabis-based products.
The cannabis plant has a wide range of industrial and medical applications. The hemp strain is used in building materials, textiles, paint and biofuel, to name a few examples, while other cannabis varieties are grown for their cannabinoid profiles. Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the best-known cannabinoids, but there are more than a 100 other compounds in this class. This huge versatility has led to a burgeoning industry centred around the cannabis plant.
The medical use of cannabis exploits the action of cannabinoids synthesised by the cannabis plant. Conditions that are treated with cannabis-derived products include chronic pain, pain associated with multiple sclerosis and spinal cord injury, nausea and vomiting caused by chemotherapy, radiotherapy and HIV therapies, appetite stimulation in cachexia, anorexia, loss of appetite in cancer patients and those with AIDS or anorexia nervosa, the hypotensive effect of glaucoma and the reduction of involuntary body and facial movements in Gilles de la Tourette syndrome.
Medical use is widespread around the world, with some notable exceptions. Obtaining authorisation is generally necessary to be able to produce, import and sell cannabis for medical use. Patients generally gain access to these products via a prescription.
Before discovering the healing properties of cannabis, its use was mainly connected to industry. Although some countries (especially in Europe) have adopted a distinction between the varieties of cannabis that, generally being used in the industrial sector, do not fall within the scope of laws on psychotropic substances, not all countries have made this distinction.
In the European Union, the cultivation of industrial cannabis (hemp) is permitted provided the variety is registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and the THC content does not exceed 0.2%. This measure has been taken with the aim of encouraging cultivation.
Industrial cannabis usually contains only traces of THC, while CBD is present. Not all countries have clear regulation on CBD.
Cannabis-based products are potentially patentable in most territories. The normal principles of patentability generally apply to these products, without ad hoc legislation.
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 5 years, an unlimited fine or both; (ii) supply and production canbe punished with imprisonment up to 14 years, an unlimited fine or both; and (iii) manufacturing/sellingby way of wholesale a medicinal product without a valid manufacturing/wholesale distribution licence,and selling/possessing for sale an unauthorised medicinal product can be punished with imprisonment up to 2 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 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.
Cannabidiol 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 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 United Kingdom, cannabis related products are potentially patentable including cannabinoid extracts, dried flowers, medical formulations and inhalation devices/systems. It may also be possible to obtain protection for cannabis plants in the United Kingdom, although the position on patentability of plants produced by essentially biological processes (in general, not specifically cannabis plants) is unclear in Europe at present. 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 onclinical effectiveness of cannabis-based medicinalproducts by the National Institute for Health and Care Excellence (NICE). The NICE guideline wassubsequently 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 resistantepilepsy. NICE is also developing technologyappraisal 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.