A Risk-based Approach to Cannabis

Hari Guliani, Head | Colombia Care International

A common question amongst cannabis industry professionals in the UK recently has been ‘how many patients in the UK have a cannabis prescription?’.  But that is the wrong question.  We would gain a much better understanding of the success of our sector and the regulatory environment by instead asking ‘what percentage of people using cannabis for a diagnosed condition source it from the legal market?’

We lack published data on the volume of unlicensed CBMP prescriptions issued privately in the UK. Whether you think that there are 5,000, 10,000 or even 50,000 patients with a cannabis prescription in the UK in January 2022 – that still means that at least 95% of those using cannabis for medicinal reasons do so from the illicit market, based on opinion poll survey responses.  


This shocking reality means there is a much greater ongoing risk of harm than was intended from the 2018 rescheduling regulations, which were designed to provide a safe and legal prescription route for cannabis-based products, and so control the risks that might result in harm to patients.


The risks we run today


The problem with illicitly sourced cannabis is the lack of transparency in the supply chain and any quality management and quality assurance process in place.  While medicinal cannabis cultivation and processing includes tests that should systematically eliminate the presence of bacteria, fungus, pesticides and residual solvents in products, illicit market supply chains do not have the same level of oversight.  Where there are issues with legally produced medicines, there are reporting systems in place and protocols designed to systematically address these.

According to a 2019 report from the European Monitoring Centre for Drugs and Drug Addiction1, the UK produces large quantities of illicit cannabis for the domestic market alongside the quantities originating in Morocco, Albania and other countries.  Other recent reports estimate the UK’s production at being upwards of 250 tonnes a year, raising concerns about the widespread use of rat and insect poisons in illicit grows with residues present in the products being consumed.2  


According to these reports, synthetic plant growth regulators commonly being used are banned from food crops given the links to them as a cause of cancer, liver problems and infertility.  Illicit grows often occupy unoccupied spaces, with news outlets reporting seizures of illicit cannabis cultivation in locations such as the basement of a commercial building in the City of London, a former Argos store in Liverpool and sites in Welwyn Garden City.  Images of these sites often show stained walls and environments that suit mold and other contaminants. The challenge of choosing buildings based on speed of set up and low likelihood of disturbance and detection becomes clear: quality just is not front and centre of mind in these operations.  


A quick search of random illicit market cannabis samples submitted to WEDINOS3 – an organisation that enables the collection and testing of psychoactive substances aimed at disseminating harm reduction advice – highlights numerous examples of undesirable contaminants including heroin, paracetamol, noscapine, aspirin, ketamine, MDMA and in some cases, synthetic chemicals (the impact of which cannot be separated from the widely reported associations with psychosis).

Can we continue to tolerate this risk of harm to patients, many of whom have been looking to avoid traditional narcotics in the first place?  How can doctors manage drug interactions effectively when it is unclear what patients are putting into their bodies?  A doctor can only use the information that is available to them to make a decision – but what percentage of patients using cannabis illicitly feel comfortable sharing this with their doctor?  


It seems safe to assume that very few patients discuss use of illicitly sourced cannabis compared with medicinal products recommended by a doctor.  We have to change this dynamic dramatically and create an environment for patients and their healthcare professionals to work together to access products that have been carefully assessed from a quality perspective, and which make sense for that patient.


So what is the answer?  The patient access conversation in the UK to date has focused on NICE and their perspective that the cost-benefit analysis has not been established to support widespread use of medicinal cannabis in the NHS.  However, there are alternative approaches to the status quo of all-or-nothing.


Two ideas to widen access and help reduce risks


First – if NHS doctors were allowed to prescribe medicinal cannabis, purchased by the patient themselves in all but the most severe cases, we would materially improve the risk profile noted above.  Without adding any cost burden for the NHS and taxpayers, we would stimulate important conversations about patient health within the doctor’s surgery.  There is precedent for this approach.  NHS dental services allow patients to self-pay for additional services.  Perhaps more relevant, is the example of Viagra over twenty years ago.

The British Medical Journal noted in 19984 the challenge faced by Viagra: there were real concerns about the cost impact of introducing this for all legitimate patients who wanted access to it.  One parallel between Viagra and medicinal cannabis is the fame and media interest in both products, far ahead of the typical route to prescribing for medicinal products.  Demand simply far outstripped supply and ran ahead of clinical experience.  This culminated in a set of regulations where GPs were permitted to write private prescriptions for patients to purchase Viagra with their own money.  Would it not be better if we did the same with medicinal cannabis? 


One parallel between Viagra and medicinal cannabis is the fame and media interest in both products, far ahead of the typical route to prescribing for medicinal products.  Demand simply far outstripped supply and ran ahead of clinical experience.  


What bears more risk: a patient alienated by modern pharmaceuticals, purchasing unknown substances from a street dealer in the unregulated market; or an NHS doctor engaging with a patient about their healthcare and their options, including self-paid medicinal cannabis, sourced from a licensed UK pharmacy?  


We know that patients would welcome this option.  In October 2021, Columbia Care International asked over 3,000 people living in the UK if they would like to be made aware of privately-paid medications not paid for by the NHS when visiting their NHS doctor. A large majority, 82%, said yes.  This demonstrates a clear appetite among the British public for alternative treatments and an openness to pay privately for them.


Was the Viagra story a success?  According to an article in The Times in 2007, Alex Gourlay, then Boots health-care director was reported to estimate that 10% of the three million men suffering erectile dysfunction were being treated.  The article in question was reporting the announcement of a pilot scheme to improve access.  Boots started a Patient Group Direction pilot in Manchester.  Such was the success of this programme that by 2010, Tesco could do the same from its 300 pharmacies. 


GPs were permitted to write private prescriptions for patients to purchase Viagra with their own money.  Would it not be better if we did the same with medicinal cannabis? 


By 2017, the MHRA allowed an over-the-counter version to be sold, called Viagra Connect, and patient uptake further expanded.  Risk management remains front and centre of the Viagra story today, with a pharmacist reviewing answers to a set of questions about the patient’s health and medication to determine whether there is an acceptable risk profile for the use of the drug.  The product’s website contains a prominent link to the MHRA’s yellow card scheme for reporting side effects, enabling centralised oversight of the ongoing risks associated with that product.  The end result is that the concerns flagged initially by the BMJ have been appropriately addressed: the financial burden does not sit with the state, but risk is being appropriately managed by healthcare professionals.


Furthermore, since 2017, and perhaps more importantly since the COVID-19 pandemic, there has been a material improvement for patients in the ease to consult a GP, with the move to video consultations.5  It does not seem far-fetched to expect that we might see a higher number of people using GP-led services now than was possible a decade or more ago, especially given the stigma or embarrassment of speaking to your village GP about sensitive subjects.


Second – for some patients, the time and effort involved in accessing the private market does not always make sense, such as patients in a palliative care environment.  Often family members will do anything to help their loved ones, including turning to the illicit market for cannabis, which can be a quicker and even less daunting route to pursue.  How can this make any sense?  Most patients say it does not.  Eight out of ten people who took part in Columbia Care International’s survey thought it was wrong to restrict healthcare professionals’ use of the cannabis plant as a medicine because of old fashioned views of cannabis as a recreational drug.  This restriction means patients are left with no choice.

In defined circumstances, where healthcare professionals and carers are deeply knowledgeable about an individual patient’s care, Patient Group Directions6 (PGDs) have been used to improve overall care to patients.  A PGD for medicinal cannabis might allow healthcare professionals providing palliative care another option for their patients, when they consider it appropriate, based on individual patient needs including quality of life.


The current guidance makes clear that PGDs are intended for use with drugs that have achieved marketing authorisation and that unlicensed and special manufactured medicines should not be included.  Changes would need to be made for this framework to improve access to medicinal cannabis, initially for particular types of patient. Further, to meet the guidance issued by NICE, a protocol would need to be developed with specialist clinicians who could determine appropriate parameters and flag where further clinical assessment would be required, but given increasing adoption by leading clinicians this is not unrealistic.


Any healthcare professional who has worked in a palliative setting knows the material impact of opioids on these patients.  When you compare the risk profile of opioids and medicinal cannabis side-by-side, our current approach of driving people to the illicit market while making opioids readily available looks misguided.


In conclusion, the question we really should ask ourselves is whether the current framework does the right thing for patients with real unmet healthcare needs.  By making patient access so difficult, in a country where so many claim to be accessing cannabis for medical reasons, this status quo creates more risk than we should accept by driving patients to the illicit market.


The question we really should ask ourselves is whether the current framework does the right thing for patients with real unmet healthcare needs


The answer is not to blame the NHS or direct our weight of expectation to NICE, who are both playing very important roles.  However, we do need to change the theatre of conversation from the street corner to the surgery and to allow patients to purchase, from their own pocket, the medicines that help them, both legally and safe in the knowledge that they are getting what they expect.


What should give us hope is that the British healthcare system has previously created mechanisms that balance the needs of patients, the needs of the nation’s finances and the need to ensure risk is managed by the appropriate healthcare professionals.  What excites me is that there are specialist doctors who are advocating for the use of medicinal cannabis for some patients.


We need to change the theatre of conversation from the street corner to the doctor’s surgery 


Now it is on industry to engage constructively with government and regulators to find a pragmatic way forward to improve legal access.  The two proposals in this paper should stimulate this conversation and, ultimately, drive better access for patients to a medicinal product that continues to change lives daily.

1)EU Drug Markets Report 2019, European Monitoring Centre for Drugs and Drug Addiction 



4) BMJ 1998;317:824

5) The impact of Covid-19 on the use of digital technology in the NHS, Rachel Hutchings