TGA Publishes Interim Medical Cannabis Rescheduling Decision

Medical Cannabis rescheduling - Australia
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Australia’s Therapeutic Goods Administration (TGA) has announced an interim decision to create new Schedule 8 entries for some medical cannabis products.

Cannabis, many cannabinoids and derived products are currently Schedule 9; in the same class as opioids.

Included in the new Schedule 8 entries would be cannabis itself (plant and flowering tops) and currently classified Schedule 9 botanically derived extracts and tetrahydrocannabinols (THC) under certain circumstances.

Controls over the substances under the proposed re-scheduling could be the restriction of access to state/territory authorised medical practitioners, clinical trials, through the TGA’s Special Access Scheme Category B or the Authorised Prescriber scheme; or through prescription from a specialist medical practitioner.

Not all cannabis products are currently Schedule 9. For example, cannabidiol (CBD)  in preparations for therapeutic use containing 2 per cent or less of other cannabinoids found in cannabis is Schedule 4.

The TGA says the reasons for the rescheduling were based on feedback from the Advisory Committee on Medicines Scheduling. This feedback included providing an appropriate safety profile to cater to growing clinical trial use of cannabis-based products and increasing “moderate-quality” evidence supporting their use in the treatment of a number of conditions.

The TGA also acknowledges advice that cannabis has low risk of physical dependence, but says “it may be a pathway to more addictive drugs”, an opinion that many medical marijuana supporters (and some studies) would strongly argue against.

While the rescheduling would be a move in the right direction, it’s still very restrictive and some say the whole process is taking too long.

The President of the Pharmacy Guild of Australia’s ACT Branch, has empathised.

“I understand it’s not fast enough for some of the people who want to use it – and a lot of the people in the community pushing for it are parents of children who have terrible outcomes, so from their perspective the quicker they can get to where their children can get these medicines that appear to be working well for them, the better,” said Amanda Galbraith in comments to AJP; the Australian Journal of Pharmacy’s online magazine.

“But we’ve also got to balance the desire for new medicines with good outcomes for some with the need to do it in a safe fashion, with appropriate trials.”

Further submissions regarding the TGA’s proposed cannabis amendment must be received by the closing date, 19 April 2016.