Most people will know that controlled drugs fall under difference Classes (A, B or C) in the UK, but what far fewer people are aware of is that drugs are also classified under different Schedules, which restrict their availability, how they are used and whether they can be researched or prescribed. Over the coming weeks, we’ll be exploring what impact the impact is of different schedules, and what could be gained from rescheduling drugs.
Background and current anomalies in the UK
At the present time, cannabis is classified as a Schedule 1 controlled drug under the Misuse of Drugs Regulations 2001. This means that it is deemed “of no therapeutic value”. This is contrary to a significant volume of studies that demonstrate that various cannabis products do have a clear medicinal value, as has recently been illustrated in the report by Professor Michael Barnes and Dr Jennifer Barnes for the APPG on Drug Policy Reform.
The issue has been debated by several sovereign states and cannabis is now recognised as having medicinal value and is legal or decriminalised for medical usage in 25 US states as well as 39 other countries.
The situation is further confused by the fact that Sativex (nabiximols) is a natural cannabis product containing equal proportions of the two main active chemicals, THC and CBD, and is classified as a Schedule 4 Part 1 drug under the same regulations and thus legally prescribable in the UK. A synthetic cannabinoid, nabilone, is also prescribable in the UK.
Non-UK European citizens who have legally obtained cannabis in their own country may legally import cannabis for continuing personal medicinal use when they come to the UK, while UK citizens who legally obtain cannabis abroad may not do so.
Until October 2016 one of the main constituent substances in cannabis, CBD or Cannabidiol, which is not psychoactive, was legal to purchase in the UK. It is particularly of known medicinal value in anxiety and types of treatment resistant epilepsy in children. In October 2016 the Medicines and Health Care Products Regulatory Agency (MHRA), which is an executive agency sponsored by the Department of Health, issued this statement:
“We have come to the opinion that products containing cannabidiol (CBD) used for medical purposes are a medicine. Medicinal products must have a product licence (marketing authorisation) before they can be legally sold, supplied or advertised in the UK, unless exempt. Licensed medicinal products have to meet safety, quality and efficacy standards to protect public health.”
In other words, the MHRA now recognise that CBD could potentially have medicinal value, although this is dependent on manufacturers providing proof of its efficacy (the MHRA ruling has arisen due to manufacturers making claims of medicinal efficacy of their CBD products). Individuals, including young children with resistant epilepsy, will not be able to obtain CBD legally from November 2016 until the producers can satisfy the regulations for medicinal products, which will take some years.
Finally, there is now a solid scientific rationale for the efficacy of cannabis given the discovery in recent years of the human endocannabinoid system. This is known to play a key role in a variety of brain functions, including the modulation of pain, nerve growth and nerve protection, brain adaptability (plasticity) and aspects of memory. It is also involved in a number of metabolic, immune and endocrine functions and seems to play a role in tumour regulation.
Overall, the regulations covering cannabis and cannabis products are confused and contradictory.
The Misuse of Drugs Regulations 2001 define in what circumstances it is lawful to possess, supply, produce, import and export controlled drugs. Drugs are divided into five schedules, with Schedule 1 containing those considered to have no therapeutic value and therefore cannot be lawfully possessed or prescribed – this includes cannabis. Drugs in Schedules 2 and 3 can be prescribed and supplied by pharmacists, doctors and anyone with a prescription – these include methadone. Schedule 4(i) can only be lawfully prescribed under prescription – this includes Sativex. Schedule 4(ii) drugs can be possessed as long as they are clearly for personal use – this includes steroids. Schedule 5 drugs are sold over the counter and can be legally possessed without a prescription.
It is possible to reschedule cannabis by Statutory Instrument. Primary legislation is not required. The logic would be to reclassify to Schedule 4(i) of the Misuse of Drugs Regulation 2001. This is the same category as the existing prescribable cannabis product – Sativex (nabiximols). This in turn would mean that cannabis becomes prescribable by doctor’s prescription.
Advantages of Rescheduling
- Removal from illegal purchase / supply: At the moment, there are between 30,000 and 1 million users of cannabis for medical purposes – see APPG report. All these users are acting illegally except for the those who have a legal prescription for Sativex, which has a licence only for use in drug resistant spasticity in multiple sclerosis, and the few people prescribed nabilone for nausea or vomiting during chemotherapy. Rescheduling of cannabis would enable these people to legally access cannabis by doctor’s prescription. This would take vulnerable, and often disabled, people out of the criminal market. The disadvantages of obtaining cannabis from the criminal market are obvious and include personal risks involved in purchase, the uncertainty of the purity of the product and the risk of exposure to other addictive drugs.
- Product purity: Legal cannabis should be produced with stringent purity criteria. This is the case in most US States and European countries that have legalised it for medical use. This enables the consumer to be reassured about the safety and quality of the product.
- Diversity of product: Cannabis can be produced in a variety of forms, particularly with variations in the relative content of the psychoactive THC component and the non-psychoactive CBD component, as well other cannabinoids which may have medicinal effects. In the Netherlands, for example, the Bedrocan range of products come in 6 different varieties. It is clear that some conditions / people respond better to a certain type of cannabis with a specific THC:CBD ratio and it is essential that different, pure, forms are available. Such control of product is not possible in the criminal market.
- Research: There is some good quality literature regarding the efficacy and safety of cannabis but there are still many aspects which require further research. We need to understand which conditions are best helped by which type of cannabis product (such as those low or high in THC / CBD). We need to understand more about the short-term side effects and we need more knowledge about potential long term problems, such as the much-discussed risk of psychosis in those already vulnerable. This research is clearly facilitated by ability the prescribe cannabis and thus enter individuals into properly conducted studies.
- Safety and reduction of opioid-related death: The main alternative medications for pain (one of the best researched indications for cannabis) are the opioid drugs. Whilst these are effective for pain they are associated with significant side effects and each year many hundreds or people die from accidental or deliberate opioid overdosage. There have been no reported deaths from cannabis overdosage. Cannabis is known to be “opioid sparing” and individuals can either stop or reduce their opioid medication giving rise to less risk of opioid side effects and less chance of death.
- Alcohol reduction: There is evidence that if cannabis is more widely used medicinally then individuals consume less alcohol with consequent decrease in the adverse social consequences of alcohol usage.
- Suicide reduction: There is further evidence that use of cannabis in those with mental health vulnerability have a lower risk of suicide.
- Finance: Legalisation of this market would enable the government to raise taxes on the suppliers (and on prescription charges to consumers). The income is estimated (by the Institute of Social and Economic Research) to be in the order of £0.5b to £1.25b if the cannabis market was opened for both medicinal and recreational use. If the reasonable assumption is used (End our Pain campaign) that one third of cannabis users are medicinal users then the tax income from medicinal legalisation would be in the range of £170m to £420m. In addition, there would be savings to the exchequer from less policing and court costs for prosecution of cannabis dealers and users, (estimate by ISER of about £300m from legalisation of the whole market). As a comparison, the State of Colorado was expected to raise $88m in 2015 from the legalisation of cannabis. Colorado’s population is about 10% of the UK.
Addressing potential disadvantages
Some express concern about crime rates if cannabis is more readily available. The APPG report cites evidence from the US that “the legalisation of marijuana for medical purposes is not predictive of higher crime rates and may be related to reductions in rates of homicide and assault”. There is also no evidence of significant traffic accident risk and a meta-analysis of 66 studies has shown that crash risk was “statistically comparable to that associated with penicillin, antihistamines and antidepressants” (APPG Report). There is no evidence that legalisation leads to greater overall marijuana usage and indeed the risk of “leakage” into the recreational market is clearly minimised by a controlled and secure supply chain.
The use of cannabis for medicinal purposes is common and the evidence that it is efficacious for several medical conditions is now strong. It is illogical to continue categorising the drug under Schedule 1 of the Misuse of Drugs Regulations. There are several advantages that would flow from rescheduling to Schedule 4(i). These advantages are mainly related to the compassionate need to stop criminalising genuine medical users but there are also a number of safety, research, and financial reasons for so doing with very few disadvantages.
Professor Mike Barnes is Clinical Director at Christchurch Group, responsible for all clinical and therapy services. A highly experienced consultant neurologist, over the last 20 years, he has been dedicated to the development of neurological rehabilitation throughout the UK and internationally.