David Hardstaff and Ami Amin discuss an in-depth report on policy developments in the UK by the Conservative Drug Policy Reform Group (the CDPRG)
In Part A: why is it still so hard for patients to access the drugs they need?
On 23 April 2020, the Conservative Drug Policy Reform Group (CDPRG) published Part A of its report, The UK Review of Medicinal Cannabis: The needs of a nation. The report is an in-depth analysis of the routes of access to cannabis-based products in the UK, both lawful and unlawful. Part A of the two-part series considers the current position while Part B, which is yet to be released, will consider the options for future regulation. The level of detail in and depth of research that has gone into Part A is impressive, making it essential reading for anyone with more than a passing interest in medicinal cannabis in the UK.
Lawful routes of access
In relation to the lawful routes of access, the report provides a comprehensive analysis of the difficulties experienced by patients in accessing medicines in the period since the 2018 rescheduling of cannabis-based products for medicinal use (CBPMs) from Schedule 1 (drugs with little or no therapeutic value) to Schedule 2 of the Misuse of Drugs Regulations 2001. In the 12-month period following the rescheduling of CBPMs, only 6,926 prescriptions were issued. The report cites several reasons for the low number, including a lack of availability through the NHS in the absence of recommendations by the National Institute for Health and Care Excellence (NICE), product licences and clinical guidelines covering limited patient populations, and regulatory restrictions arising from the classification of CBPMs, largely as Schedule 2 and Class B controlled drugs.
CBPMs may be supplied to patients in one of three ways: as licensed medicines with marketing authorisation by the MHRA; as unlicensed ‘specials’, subject to strict requirements under the Human Medicines Regulations 2012; or as part of a clinical trial. At the time of writing, only three CBPMs have received marketing authorisation.
When unlicensed, i.e. without marketing authorisation, a CBPM may only be prescribed as an unlicensed ‘special’ by a doctor on the GMC’s Specialist Register, or by a doctor acting under the instruction of specialist doctor. The prescription must be:
- in response to an unsolicited order;
- manufactured and assembled in accordance with the specification of a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber, or supplementary prescriber; and
- for use by a patient for whose treatment that person is directly responsible, in order to fulfil the special needs of that patient (and meet conditions specified in the Human Medicines Regulations 2012).
Between November 2018 and October 2019, unlicensed CBPMs, excluding Epidyolex, accounted for only 3% of prescriptions. In view of the small number of licensed CBPMs available, securing a prescription for an unlicensed product – which may have been proven to be effective and safe in other jurisdictions – may represent a route of access for a wide range of patients. However, regulatory hurdles have significantly limited the number in practice.
Issues with lawful routes
In addition to strict regulatory requirements, the CDPRG report highlights a lack of ‘prescriber willingness’ as being a significant factor in the limited number of prescriptions. Specials medicines are not licensed or subject to the same rigorous trials to determine efficacy, safety and quality as licensed medicines, presenting challenges for doctors in exercising clinical judgement when prescribing CBPMs. Against a backdrop of limited medical training in cannabinoid medicine, limited UK-based evidence of its efficacy, and, concerns regarding the known health risks posed by cannabis generally, the lack of prescriber willingness is not surprising, particularly where other licensed medicines are available.
Patient groups have criticised the current regulations as being overly restrictive, preventing most patients from accessing CBPMs. Some have described an inequity of access, where only patients with sufficient means can access CBPMs through a limited number of private clinics, established since the rescheduling of CBPMs in 2018. (Of the 204 known prescriptions issued for unlicensed specials in the year since the rescheduling of CBPMs, 85% were private.) Access via the NHS however has been limited, due to the approach of NICE and a lack of UK-based research.
The need for more research
The most recent NICE guidelines (November 2019) recommend the use of CBPMs in relation to several indications, including intractable nausea and vomiting and spasticity; however, plainly much more research is needed. On this issue, the data compiled by the CDPRG in relation to licensing makes for interesting reading and suggests a sharp rise in research projects. 20 high-THC cultivation licences (an increase of 300% since 2014) and 362 domestic licenses covering possession of cannabis under Schedule 1 were issued in 2019. As Schedule 1 licences may only be issued for ‘research or other special purpose’, it is safe to assume that most of these licences will be for the purpose of carrying out some form of research. However, any ongoing research is clearly at an early stage, with only 10 distinct cannabis-based investigational medicinal products tested in human clinical trials in the UK.
The CDPRG’s findings in relation to the lawful routes of access are thorough and in line with what most with an interest in the field would have expected 18 months after the rescheduling of CBPMs.
Unlawful routes of access
The second chapter of Part A of the report tells a very different side of the story and considers the estimated 1.4 million people in the UK who are dependent on unlawful routes of access to cannabis-based products for medicinal reasons.
Most users are reliant on the criminal market; however, the report finds that approximately half of those who grow cannabis at home do so for medicinal purposes. There is also evidence of an increased prevalence of collectives, or ‘cannabis social clubs’, through which individuals pool resources and advice on effective cultivation methods. Many of these clubs, some of which offer safe spaces for members to use cannabis, are known to, and in some cases, tolerated by the local police.
As with the barriers experienced by many patients with a genuine need to access CBPMs, there is some inequity in the varied and inconsistent approach taken by law enforcement when permitting or policing access to cannabis or cannabis-based products. We have already seen an erratic distribution of penalties for minor offences across the country. Clearly, this is unsatisfactory and results in greater uncertainty. There is unlikely to be an easy solution: a national policy might iron out the inconsistencies, but at the risk of losing sensitivity to the varying needs of individuals and communities.
Part A of the CDPRG report cogently sets out the existing routes to access medical cannabis, and the various shortfalls in the current law. Part B of the report will no doubt provide an equally meticulous evaluation of the anticipated regulatory reform in this area and is keenly awaited by all those affected. In the meantime, BCL Solicitors LLP can provide discreet and bespoke legal advice in relation to all legal and regulatory aspects of the UK’s controlled drug regime.