Medical cannabis in the UK

Is medical cannabis legal in your jurisdiction?

The law relating to cannabis is complex and evolving. Cannabis-based products for medicinal use in humans may only be used in strictly defined circumstances.

Cannabis is designated a Class B controlled drug under Part II, Schedule 2, of the Misuse of Drugs Act 1971 (MDA 1971). As a general rule, it is unlawful to possess, supply, produce or import/export controlled drugs except under a Home Office licence.

The Misuse of Drugs Regulations 2001 (MDR 2001) provide a legal framework for access to controlled drugs for legitimate purposes. The Regulations set out different levels of authorised activity for controlled drugs classed under different Schedules. Schedule 2 includes drugs with therapeutic value but regarded as highly addictive.

There are three categories of product that may be made available as medicines.

Licensed medicinal products

A small number of cannabis-based products are covered by a UK marketing authorisation. These may be made available in accordance with the relevant authorisation.

CBPMs

Unlicensed medicines may be prescribed on an individual patient basis in response to the patient’s special needs. A new category of “cannabis-based products for medicinal use in humans” (CBPMs) was added to Schedule 2 MDR 2001 in 2018. This allows CBPMs that aren't licensed as medicinal products to be prescribed by a doctor who is on the General Medical Council (GMC) Specialist Register without the need for a Home Office licence.

A CBPM must satisfy the following requirements to fall within the definition of a CBPM; the product:

1. Is or contains cannabis, cannabis resin, cannabinol, or a cannabinol derivative (not being dronabinol or its stereoisomers)
2. Is produced for medicinal use in humans
3. Is a medicinal product or substance or preparation for use as an ingredient of, or in the production of a medicinal product

Investigational medicinal products:

A CBPM as an investigational medicinal product can still be used in clinical trials provided that the legislation applicable to clinical trials is complied with.

Note that ‘pure’ cannabidiol (CBD) only-based products (including synthetic versions) aren't classified as a cannabis-based product for medicinal use and are not considered controlled drugs as they contain very small amounts of THC. To be exempt from scheduling a product will need to fulfil the three limbs of the “exempt product” definition in the MDR 2001.

What is the legal framework/What are the requirements for

• Growing and manufacturing medical cannabis

• Marketing medical cannabis

• Purchasing medical cannabis (hospitals, doctors or patients)

• Are there any import restrictions for medical cannabis

• Marketing products containing medical cannabis both to resellers and consumers?

As discussed above, cannabis is a Class B controlled substance under the MDA 1971. It's therefore unlawful to possess, supply, produce, import or export this drug without a licence from the Home Office, unless a medicinal product or limited ‘exemption’ applies under the MDR 2001, eg a pharmacist or person conducting a retail pharmacy business acting in their respective capacities.

Organisations wishing to possess, supply, produce, manufacture, import/export CBPMs will normally require a Home Office Controlled Drug licence to lawfully undertake these activities.

Cultivation of any cannabis plant requires a Home Office licence or otherwise is unlawful, regardless of THC content or medicinal purpose. There are two licensing schemes for cultivating low-THC and high-THC varieties. Licences are granted for either research or ‘other special purposes’.

Marketing of CBPMs isn't permitted, as they are unlicensed medicinal products. Authorised medicinal products may be marketed in compliance with applicable law and guidance.

What is the legal procedure to apply for respective permissions outlined above, if any, and who are the competent authorities?

Where an organisation needs to obtain a Controlled Drug licence, it must apply to the UK Home Office. An application will require registration as a customer on the controlled drugs licensing system and any person named on the application must hold a valid Disclosure and Barring Service (DBS) check. Each application is considered carefully on its merits taking account of the ability of the applicant to comply with regulatory standards in order to be issued with a licence under the MDR 2001. The Home Office also takes into account the applicant’s ability to satisfy the requirements of other relevant regulatory bodies (such as the MHRA) when deciding whether it would be appropriate to grant a licence, where they are relevant to the risk-based licensing assessment process that it operates.

There are fees payable when applying for a licence, normally invoiced once a decision to grant has been made. These can be up to £4,700, depending on the class of activity for which the licence is sought. The Home Office will arrange a compliance visit for new licence applications (which may be up to 16 weeks after application) to check company’s compliance with drugs regulations. Renewals may also involve a site visit.

Are there developments to be expected within the legal framework in your jurisdiction?

Various attempts have been made to make it more straightforward to obtain access to cannabis-based medicinal products, although none of these are currently actively progressing. We don't envisage major changes in the short term, although a change of Government, for example, could lead to further reform.

Are there any financial benefits (state aid, tax benefits, etc.) implemented to foster the medical cannabis industry?

We're not aware of schemes of this nature currently operating. However, where a patient is prescribed a CBPM or licensed medicinal product in the course of NHS treatment, the cost of this treatment will normally be met by the NHS.

Within the framework for medical cannabis in your jurisdiction, is there opportunity or scope for entrepreneurs in the wider eco system (eg information sharing between practitioners or patients)?

The complex and strictly controlled regime for medical cannabis in the UK means that entrepreneurs and investors remain cautious. There is, however, growing interest in meeting demand for this class of products. The recently launched UK Cannabinoid Research and Development Group, co-chaired by Professor Trevor Jones (formerly R&D lead at Wellcome PLC and Director General of The Association of the British Pharmaceutical Industry) and George Freeman MP, focuses on integrating UK universities, research institutions, businesses and the NHS. The CRDG aims to develop and execute a strategy to establish the UK as a global leader in R&D in cannabinoid science and will present an initial strategy paper to Government in summer 2024.

In addition, patient advocacy groups arguing for greater access seek to engage with business and healthcare providers.

Are there any jurisdictional specific requirements, rules or procedures that have to be followed in your area that other jurisdictions may not have?

The complex and strictly controlled regime for medical cannabis is specific to the UK, and is likely be perceived as more restrictive than many other jurisdictions.