By Partner, Dr Teresa Nicoletti and Lawyer, Helaena Short.

The World Health Organisation’s Expert Committee on Drug Dependence has published its initial report on the international controls which should be applied to cannabidiol (CBD) and concluded that current information does not justify scheduling of CBD.

Background to the Report

Historically, cannabis has never been subject to a scientific assessment by the United Nations (UN). Cannabis was last reviewed in 1935 by the League of Nations, however, the review focussed on moral and racial stereotypes and glossed over any relevant scientific data.

Perhaps unsurprisingly in this regard, ‘cannabis’, being the flowering or fruiting tops of the cannabis plant, and ‘cannabis resin’ are currently listed in Schedules I and IV of the Single Convention on Narcotic Drugs (1961), being the strictest schedules for substances with little or no recognised therapeutic value.

Notwithstanding this, medicinal cannabis has accelerated to the forefront of drug policy reform discussions all over the world, and 40 jurisdictions worldwide (in 16 countries) have moved to regulate cannabis for therapeutic purposes.[1]

The International Narcotics Control Board (INCB) has also recognised the medicinal properties of cannabis and has reported that the ‘licit use of cannabis, including for medicinal or research purposes, has increased considerably since 2000.

Undoubtedly in light of this emerging international interest, the UN’s attention to cannabis has increased over recent years. In 2015, members of the World Health Organisation’s (WHO) Expert Committee on Drug Dependence (ECDD) requested further evaluation of the cannabis plant and its components, and in 2016 WHO’s Director-General wrote:

“The [ECDD has] recognised: an increase in the use of cannabis and its components for medical purposes; the emergence of new cannabis-related pharmaceutical preparations for therapeutic use; cannabis has never been subject to a formal pre-review or critical review by the ECDD.”

Relevantly, the ECDD set an 18-month timetable to receive additional information and compile evidence to evaluate the position of cannabis, cannabis extracts and tinctures and related compounds within the bounds of international drug control policy.

Report Findings

Cannabis comprises more than 100 chemical compounds called cannabinoids, the most common of which are cannabidiol (CBD) and tetrahydrocannabinol (THC), the primary psychoactive component of cannabis. The ECDD’s Pre-Review Report (Report) is available here and specifically addresses the scientific and regulatory status of CBD. The ECDD will undertake a more comprehensive review and release its final report, including recommendations to the United Nations Secretary General, in May 2018.

The Report acknowledged that the clinical use of CBD is most advanced in the treatment of epilepsy. In several human and animal studies, CBD has been observed to have some therapeutic value for seizures due to epilepsy and related conditions. In clinical trials, CBD has been demonstrated as an effective treatment for at least some forms of epilepsy.

Furthermore, the Report acknowledged that there is preliminary evidence (a combination of pre-clinical and limited clinical evidence) supporting the use of CBD in the management and treatment of several other conditions and diseases including:

• Alzheimer disease;
• Parkinson’s disease;
• Multiple sclerosis;
• Huntington’s disease;
• Hypoxia-ischemia injury;
• Pain;
• Psychosis;
• Anxiety;
• Depression;
• Cancer;
• Nausea;
• Inflammatory diseases;
• Rheumatoid arthritis;
• Infection;
• Inflammatory bowel and Crohn’s disease;
• Cardiovascular diseases; and
• Diabetic complications.[2]

Having regard to the observed neuroprotective, antiepileptic, anxiolytic, antipsychotic, analgesic, anti-inflammatory, anti-asthmatic, and antitumor properties of CBD, the therapeutic applications of CBD are only likely to increase as the research base continues to expand.

Notably, the Report concluded that CBD is generally well-tolerated and has a good safety profile. The Report found that there is no evidence of recreational use or any public health related problems associated with the use of pure CBD and, further, that CBD has no related abuse or dependence potential.

Implications for the future of CBD

The Report echoes the expert recommendations which were published prior to the ECDD’s meeting on 6-10 November 2017, the second of which concluded:

“Based on available evidence CBD lacks psychoactivity, reinforcing properties and abuse liability. On the other hand, emerging findings suggest promising therapeutic usefulness. Scheduling this substance could impact accessibility for scientific and medical research.”[3]

In our view, the ECDD’ s conclusion that the current state of research does not justify scheduling of CBD is a compelling reason why the Schedule 4 status of CBD in Australia is not justified. If the ECDD’s final recommendations in May 2018 reaffirm, or reinforce, the Report’s conclusions, then there would be no legitimate basis for the Secretary of the Department of Health to maintain the present restrictions on CBD.

In our view, where the evidence clearly establishes that CBD has a good safety profile, has no related abuse or dependence potential and there is no evidence of recreational use, there is no persuasive reason for medicinal products containing CBD to only be available under prescription. If CBD (in preparations for therapeutic use containing 2% or less of other cannabinoids) was to be de-scheduled (i.e. removed from the Poisons Standard altogether) and concurrently added to the Permissible Ingredients Determination, the burden for Australian companies to develop, manufacture and supply medicinal products containing CBD for a broad spectrum of therapeutic applications would be substantially reduced. This would improve access for all Australians to novel and effective therapies, in the absence of concerns about a risk to public health or safety.

Concluding remarks

We support the attention and dedication the ECDD has promised to understand the current state of research surrounding the therapeutic applications of CBD. The Report is an early but significant step in a process which is likely to shape how CBD is regulated internationally in the future.

We endorse the ECDD’s preliminary conclusion that current information does not justify the scheduling of CBD. In anticipation that the ECDD will make final recommendations next year which reinforce this conclusion, it is likely that the State and Federal governments will need to seriously reconsider their present stance on CBD and, more broadly, the regulation of medicinal cannabis products containing CBD as the predominant component.

[1] For example, Argentina, Brazil, Canada, Chile, Colombia, the Czech Republic, Germany, Israel, Jamaica, Mexico, the Netherlands, Peru, Puerto Rico, the UK, several US states and Uruguay.

[2] For the original review publication see: S Pisanti et al.’Cannabidiol: State of the art and new challenges for therapeutic applications’ (2017) 175 Pharmacol Ther 133-150.

[3] ECDD 39^th Meeting, Geneva 6-10^th November 2017, Expert Peer Review No. 2, para 1(g); also see, Expert Peer Review No. 1.