TGA Recognised WHO Findings on Cannabidiol Three Years Ago

Recent media reporting suggesting that the World Health Organisation had determined that there were no public health risks with medicinal cannabis or ‘medical marijuana’ are untrue.

These articles distort the findings of a recent report that the WHO gave to the United Nations relating to whether or not pure cannabidiol (CBD) – the main non-psychoactive substance extracted from cannabis – should be subject to international restrictions.

The WHO report did not look at medicinal cannabis itself nor the psychoactive component, THC.

The findings of the WHO mirror those made by the TGA almost three years ago. At that time TGA decided to re-classify cannabidiol from being a “prohibited substance” (Schedule 9) to a “prescription medicine” (Schedule 4) in the Poisons Standard.

The WHO was assessing CBD to determine whether it is psychotropic, addictive and subject to potential abuse.

It determined that it is not psychotropic and therefore recommended that it not be ‘scheduled’ under either of two international treaties – the Single Convention on Narcotic Drugs 1961 and the Convention on Psychotropic Substances 1971.

Back in Australia, in 2014, the Advisory Council on Medicines Scheduling recommended rescheduling cannabidiol from a prohibited substance to being a prescription medicine because ‘there is a low risk of misuse or abuse as cannabidiol does not possess psychoactive properties’. The TGA accepted this recommendation and the decision took effect in July 2015.

We emphasise that scheduling as recommended by WHO under international treaties and scheduling in Australia under the Poisons Standard deal with two quite different matters.

International scheduling places controls on international trade and production of particular substances to prevent diversion, abuse, misuse and trafficking.

Scheduling in the Australian context (the Poisons Standard) determines how a substance should be made available to patients (for example on prescription, over the counter in pharmacies or on general sale through supermarkets and other outlets).

CBD remains prescription only in Australia because the conditions that it might be used to treat, such as epilepsy, are serious medical conditions and require medical diagnosis and oversight.

It is for this reason that cannabidiol is not available ‘over the counter’.

As there are no registered CBD products at this time in Australia, access to these products is through the TGA Special Access Scheme, the Authorised Prescriber Scheme or clinical trials.

More information on accessing medicinal cannabis products is available on the TGA website.
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What is ‘medicinal cannabis’ or ‘medicinal marijuana’?

Medicinal cannabis is any product derived from the cannabis plant for medicinal purposes.

It contains a range of ‘cannabinoids’, of which CBD is just one. The other major cannabinoid is ‘delta-9-tetrahydrocannabinol’ or THC, which is responsible for the psychoactive character of cannabis or marijuana.

THC may also have important medical applications.

THC is scheduled in the 1971 Convention on Psychoactive substances and is subject to international controls.

Cannabis is scheduled in the Single Convention on Narcotic Drugs and is similarly subject to international controls.
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Further action

The WHO report was a ‘pre-assessment’ report. The WHO recommended that CBD be subject to full assessment in 2018. The TGA will continue monitor these and other international developments.