UK Cannabis Legalization
In the last few months an exciting piece of news has been around the United Kingdom taking steps towards legalizing medical cannabis. Here’s a short boil-down of what’s happening.
In the summer, a 12-year-old boy named Billy Caldwell was prevented from obtaining his medical cannabis for his epilepsy. The political event sparked tremendous debate in the UK, and which quickly pushed the government into the conversation. Shortly thereafter, the UK announced that it would commit to revisiting the status of medical cannabis available to people in the UK.
In the process of rescheduling medical cannabis (called Cannabis-Derived Medicinal Products, or CDMP’s), on August 15/18 the Advisory Council on the Misuse of Drugs (ACMD) working group met with the representatives of the Home Office, the Department of Health and Social Care (DHSC) and the Medicines and Healthcare products Regulatory Agency (MHRA). Earlier this week, the ACMD provided recommendations around rescheduling medical cannabis. Although at this stage it is only one recommendation among several expected, it is nonetheless a strong indication of where the UK may land with regards to cannabis legalization.
The Government’s prior proposal around the definition of a CDMP included flower, resin, cannabinol and derivatives. However, the ACMD believes this definition is too broad, with no reference to safety or quality standards. The ACMD is therefore recommending a narrower definition.
The ACMD is also proposing three ways to access medical cannabis in the UK. First, a medical practitioner could prescribe cannabis as an unlicensed medicine. Second, the medical cannabis could be an investigational medicinal product without marketing authorization for a clinical trial. Third, a medical product with market authorization. It should be noted, however, that the ACMD is recommending the provision of guidance around what conditions qualify for medical cannabis, and only after other options are exhausted; it is uncertain how proscriptive this guidance will be with regards to medical practitioners using their own judgment.
The ACMD agrees with the involvement of the National Institute for Clinical Excellence (NICE) to develop substantial guidance to replace the interim guidance in due course. The substantial guidance should also address formulations, covering aspects such as high/low THC products, THC/cannabidiol (CBD) ratios and inhalable and edible products. The interim guidance will also include guidance for clinicians and pharmacists in the dispensing and sourcing of cannabis. The ACMD is also advising against the allowance of smoking cannabis.
Perhaps the most significant aspect of their recommendations that will impact Canadian licensed producers, is around the quality and supply chain management. The ACMD is advising that medical cannabis be properly labeled and manufactured to high quality standards. The initial supply of medical cannabis will, by necessity, come through importation from foreign markets – such as Canada. Considering that the United Kingdom has roughly twice the population of Canada, a new export market for Canadian producers could be a significant driver of Canadian production.
In theory, in order to export medical cannabis wholesale from Canada to the UK, a Canadian licensed producer would need to achieve EU GMP certification, similar to the requirement exporting to Germany. Also similar to Germany, importation is expected to be a near-term opportunity, whereas domestic production within the UK is expected to begin in the years ahead (although there is no indication of when or how).
It should be noted that before the Home Office can set the rules, two additional stakeholders must weigh in (DHSC, MHRA).
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Bernard Brooks says
A fine article.
The MHRA has already recommend that some cannabis products be moved to schedule 2, which the home secretary agreed to. He then sent them away again to recommend which cannabis products be re-scheduled. Additionally, the ACMD have been charged with deciding what afflictions are eligible for treatment with CDMPs.
My gut feeling is that only a limited number of conditions will qualify - severe forms of epilepsy such as Dravets. Although this could lead to a pathway through the UK’s legal system for additional afflictions to be admitted, and additional ways of consumption to be permitted., it is a nuisance.
Also, I fear that raw flower will remain in schedule 1, sadly, in order to appease a “we’re legalizing pot!” media frenzy. The worst case scenario is that only oil of restricted THC content will be the only CDMP to be re-scheduled.
However, that small chink in the armour would (I believe) provide a route through the UK supreme court for further relaxation of UK laws. But it’s going to need deep pockets…