On 10 August 2023, NHS England published a summary of key guidance and advice on cannabis-based products for medicinal use (CBPMs) to support prescribers of such products.
CBPMs have been available via prescription since 1 November 2018, following a review of CBPMs and recommendations from the Advisory Council on the Misuse of Drugs.
This article seeks to draw attention to the main takeaways provided by NHS England, as well as provide additional regulatory insight into the background status of cannabis and CBPMs. For the avoidance of doubt, this article constitutes neither legal advice nor medical advice and should not be relied upon as such.
The legal status of cannabis (and associated substances)
Cannabis, cannabis resin, cannabinol, and cannabinol derivatives (including any products which contain THC, the main psychoactive compound found in cannabis) are listed as "controlled drugs" under Schedule 2 to the Misuse of Drugs Act 1971 (the Act). In short, the Act provides that any dealing with a controlled drug is unlawful, unless and to the extent that it is permitted by regulations made by the Secretary of State and/or a licence granted by him.
Therefore, subject to any applicable exemption, it is unlawful to possess, supply, produce, import or export cannabis (including those associated substances listed above).
The legal status of CBPMs
A CBPM is defined under Regulation 2(1) of the Misuse of Drugs Regulations 2001 (the 2001 Regulations). In summary, a CBPM should satisfy the following requirements:
- It must contain cannabis, cannabis resin, cannabinol or cannabinol derivative;
- It must be produced for medicinal use in humans; and
- It must be a medicinal product (from a regulatory perspective) or otherwise be an ingredient of a medicinal product.
Since 1 November 2018, by virtue of the introduction of a new Regulation 16A into the 2001 Regulations, CBPMs are exempt from some of the restrictions otherwise applicable under the Act to controlled substances.
Regulation 16A (far from being a general liberalisation of CBPMs in England) exempts from the prohibitions under the Act those who may order or supply for administration a CBPM in three circumstances:
- The CBPM has a marketing authorisation (i.e. it is a licensed medicine) – for example, NHS England identifies cannabidiol oral solution (Epidyolex®) as a licensed CBPM that has been through randomised controlled trials for epilepsy syndromes (Dravets syndrome, Lennox-Gastaut syndrome and tuberous sclerosis complex);
- The CBPM is being used for the purposes of a clinical trial (an 'investigational' medicinal product) – NHS England observes that such products will have been assessed by the Medicines and Healthcare Products Regulatory Agency (MHRA) for safety, quality and efficacy (this is not the case for unlicensed medicines); or
- The CBPM is being administered under the prescription or direction of a 'specialist medical practitioner' (see 'The power to prescribe' below).
The third category is more expansive in that it allows any CBPM to be supplied under the prescription or direction of a specialist medical practitioner. As NHS England observes, "there is no restriction in law for which indications CBPMs may be prescribed" and "when prescribing CBPMs, it is a clinical decision to determine the most appropriate treatment for a patient".
However, as NHS England's publication makes clear, the decision to prescribe a CBPM is not one which should be taken lightly.
The power to prescribe
The power to prescribe CBPMs is restricted to professionals on the General Medical Council's (GMC) Specialist Register.
This power applies to both private specialist doctors in the UK and specialist NHS providers. However, NHS England highlights that, in the NHS, decisions to prescribe CBPMs should be based on a multidisciplinary team discussion, and the Chief Medical Officer expects clinicians in a non-NHS setting to follow equivalent processes for prescribing unlicensed special medicines.
It is possible legally for a GP or other non-specialist doctor to continue prescribing a CBPM, however NHS England makes clear that all prescriptions must be initiated and signed by a specialist doctor and it is expected that patients receiving such products will remain under the direct care of a specialist doctor in the first instance. NHS England clarifies that "the NHS will not take on shared care from a private prescriber for a treatment not commissioned on the NHS, unless there are exceptional circumstances and approval from commissioners has been sought and agreed".
The specialist doctor in any given case accepts clinical and professional responsibility for that prescribing decision.
Therefore, as required by GMC, prescribers must only prescribe drugs when they have adequate knowledge of the patient's health, are competent to prescribe for that clinical condition and are satisfied that the drugs serve the patient's need. Such decisions must take into account relevant GMC guidance and NHS Trust governance procedures.
The law does not permit private prescriptions from outside of the UK as these do not fall within the clinical scope of the GMC Specialist Register.
NHS England acknowledges that there is most evidence of clinical effectiveness in the areas where licensed products are now available (e.g. Epidyolex®), and indicates that prescribers should "always first consider prescribing medicines that are licensed for the specific condition that the patient presents with". In addition to severe treatment-resistant epilepsy, this includes intractable nausea and vomiting and multiple sclerosis (MS) related spasticity.
However, even in such cases where the product is licensed, CBPMs should be prescribed only where other (non-cannabis based) pharmaceutical treatments have been tried and are not effective. For example, in respect of the product Sativex® (which is used to treat moderate to severe spasticity in adults with MS), NHS England refers to National Institute for Health and Care Excellence's (NICE's) guidance which recommends a four week trial only if other pharmacological treatments are not effective. If the trial is effective, then prescribing can be continued.
There are currently no licenced CBPMs available for use in pain, and the evidence for use of such products for pain is not yet sufficiently developed.
In terms of unlicensed medicinal products, NHS England explains that medicines may be prescribed on the NHS where there is an "exceptional clinical need and where the benefits outweigh any potential risks as determined by the specialist doctor". However, NHS England caveats this with the fact that many doctors and their professional bodies "remain concerned about the limited evidence on the long-term safety and efficacy of these products", pointing out that "rare or unexpected side effects can develop once prescribing is more widespread and for a longer duration". In prescribing an unlicensed CBPM, the prescriber is accepting increased medico-legal responsibilities due to the absence of regulatory oversight.
NHS England makes clear that, whether or not a specialist doctor is working for the NHS, it will receive support and guidance on the evidence for the use of CBPMs and the circumstances in which they may be prescribed.
Local controlled drugs accountable officers will additionally monitor prescribing decisions.
Since 1 April 2022, NHS England has been running a patient registry to store information on the prescribing of both licensed and unlicensed CBPMs, to be completed by NHS clinicians working within NHS trusts whenever such a product is prescribed. NHS England explains that anonymised data from the registry is accessible by itself, Trusts and other relevant central organisations, while clinicians may access patient identifiable data.
CBPMs is an area limited in regulatory oversight and practical evidence of safety and efficacy. While NHS England's guidance does not seek to change existing processes and/or standards of compliance, it is a useful reminder for prescribers that in prescribing CBPMs they need to consider and take account of the risks, safety and efficacy of such products and serves as a useful reference point for the legally compliant and recommended approach. Specialist doctors operating in the field of CBPMs would therefore do well to familiarise themselves with the advice and information provided by NHS England, as well as the array of related guidance to which it refers.
For more information on cannabis-based products for medicinal use, or to discuss any of the points raised in this article, please contact our Head of UK Cannabis Group, Samantha Myers, or one of our Public Law & Regulation Team Ravi Randhawa or Emma Kensett.