Will the United Kingdom follow the US example and reform its cannabis laws?
Despite the worldwide trend in recent years calling for the liberalization of cannabis laws, the United Kingdom has maintained its hostile attitude toward reform of its domestic drug policy, and it has demonstrated few real signs of progress compared to the United States and many European countries. Currently, British media outlets tend to emphasize the perceived dangers of cannabis — often on the basis of erroneously interpreted scientific data — while disregarding the abundant evidence attesting to its safety and efficacy as a medical treatment.
In an effort to counteract negative bias toward cannabis, the lobby group CLEAR Cannabis Law Reform published a recent report of existing peer-reviewed research on cannabis, cannabinoids and their medicinal properties.
The report aims to set out in a clear and definitive manner the vast body of research providing empirical evidence of cannabis’ ability to treat numerous important conditions. Indeed, so much literature was available that it had to be narrowed down to the most well-studied conditions, and those on which cannabis apparently has the greatest effect.
The conditions discussed in the report are: cancer, multiple sclerosis, Crohn’s Disease, Alzheimer’s disease and chronic pain. Each of these conditions place significant burden on the health care system in Britain and elsewhere in the developed world, and there is ample evidence to suggest that cannabis could represent substantial improvements in cost, safety and efficacy compared to conventional medications, if legalization and regulation were implemented effectively. For example, recent clinical trials using cannabis to treat Crohn’s Disease demonstrated that 50% of participants achieved clinical remission of symptoms, with 90% experiencing some degree of improvement.
With multiple sclerosis, a condition that is becoming increasingly prevalent in the developed world — and one for which current treatment options are limited — there is general consensus among scientists that cannabis is effective as a palliative treatment. There is even evidence to suggest that it can lead to repair of the myelin sheath surrounding the spinal cord, the scarring of which is the underlying cause of the disease itself.
Fundamental problems with the current system of market approval for new medicines underlie the issue of bringing medical cannabis to those that need it. Many existing pharmaceuticals are approved on the basis of a single clinical trial, and there is a significant level of cherry-picking of data occurring, so that any potential lack of efficacy or negative effects may be unobserved for years after a medicine is approved.
Conversely, the question of the safety and efficacy of medicinal cannabis has been pored over intensively for decades — and cannabis itself has been safely used by humans for millennia — and despite the weight of evidence in favor, the bar is set far higher due to political obfuscation. The result is that countless questionable medicines make it through the approval process, while a medicine that has been repeatedly proven to be safe is sidelined.
The nature of the current model of market approval for pharmaceuticals strongly favors single-molecule preparations. However, as multiple studies have indicated, cannabis has various synergistic effects (collectively known as the “entourage effect”) borne of the unique and vastly complex ratio of cannabinoids, terpenoids and flavonoids contained within its resin. Thus, although single molecules contained within it such as THC and CBD undoubtedly have medicinal properties when used in isolation, it is by its very nature not a single-molecule substance.
This is by no means an insurmountable problem, given that the British company GW Pharmaceuticals has already set a global precedent by achieving market approval for its proprietary medication, Sativex, which is a whole plant extract of cannabis, and as such is the world’s first approved pharmaceutical that is not composed of a single molecule.
However, the cost of Sativex is extremely high, and it has been rejected as too expensive by the majority of Clinical Commissioning Groups (CCG). Furthermore, the National Institute for Health and Care Excellence (NICE) recently advised that Sativex is “not a cost effective treatment.” Thus, patients in need are subject to a “postcode lottery”; if unlucky enough to live in the wrong catchment area — or even to move to a different area from a previously more favorable one — one’s needs will simply not be met.
There appears to be very little valid reason for the cost of Sativex to be this high, particularly since the Dutch government’s preferred source of medicinal cannabis, Bedrocan BV, is able to produce equivalent cannabinoid levels for 5-20% of the end cost.
The legality of prescribing Bedrocan products is a gray area. Although a number of doctors have prescribed Bedrocan products as unlicensed medications to patients in the UK, legal advice has now revealed that doctors’ prescribing rights in respect of cannabis were specifically withdrawn in 2001. Currently, there are a handful of patients that have obtained prescriptions from British doctors, who take their prescriptions to the Netherlands to be filled, and then return to the UK with their medicine without hindrance from the authorities. However, these cases are few and far between.
Will the UK Reschedule the Drug?
Thus, the thousands of potential medical cannabis patients currently resident in Britain — many of whom suffer from illnesses that are either untreatable or only partially treatable with conventional medications — must opt for private health coverage in order to receive Sativex; consider relocating to areas of the UK (or even other European countries) that benefit from Sativex on the National Health Service (NHS); or be prepared to break the law in order to cultivate or purchase a supply of cannabis.
Adding to the problem is the prohibitive cost (up to £103,000) of applying to the Medicines and Healthcare Products Regulatory Agency (MHRA) for marketing authorization, which will discourage all but the most well-funded companies from making applications under this framework. On the other hand, attempting to gain approval for use of cannabis as a herbal medicine would preclude its use as a primary treatment for serious conditions, and would undoubtedly be deemed inappropriate, as herbal medicines are sold over-the-counter or in supermarkets, without the need for prescription or a doctor’s supervision.
On the basis of the arguments set out, the CLEAR report recommends that cannabis be rescheduled from Schedule I to Schedule II of the Misuse of Drugs Regulations, which would alter its status from that of a drug of no therapeutic value to one with therapeutic value, but with a high risk of addiction.
It is also vital to reconsider the regulatory framework for approval of plant-based medicines, so that whole-plant extracts and raw cannabis can be brought to the patient in a more effective, consistent and timely manner, and can be prescribed by doctors to the patients that need it most.
The views expressed in this article are the author’s own and do not necessarily reflect Fair Observer’s editorial policy.