Rhys Cohen

Making sense of the recent changes to our medicinal cannabis laws

Believe it or not, Australia is a world leader when it comes to regulating medicine. On the topic of medicinal cannabis, however, there are many noses out of joint.

 

 

I have tremendous respect for the way Australia regulates medicines. I tell people all the time about the rigorous standards, the science-based policy, and how this ensures quality and safety for patients. I think, on average, we regulate medicines better than almost any other country.

And this extends to medicinal cannabis as well. Despite being somewhat late to the table, we’re still years ahead of most other countries. At the global level, we’re actually quite pioneering when it comes to medicinal cannabis.

When we legalised medicinal cannabis back in 2016, we were told the existing regulatory system would not bend to cannabis, but cannabis would be bent to fit the system. Cannabis would be legalised for medical purposes, and regulated like any other medicine, with all the standard checks and balances Australians have come to expect.

We recently had a massive success in expanding patient access to medicinal cannabis in Australia. The Liberal Party didn’t want it, the TGA and ODC didn’t want it, the RACP didn’t want it, but we got it. I say ‘we’, but I had nothing to do with it – it was the patients and grass roots activists that deserve the credit.

But this victory needs to be put in context: the reason patient access has been expanded due to this legislative change isn’t because we succeeded in creating some special rule to make it easier for people to access cannabis. It’s because we removed a special rule that had been created to restrict access to cannabis medicines.

 

When we legalised medicinal cannabis back in 2016, we were told the existing regulatory system would not bend to cannabis, but cannabis would be bent to fit the system. Cannabis would be legalised for medical purposes, and regulated like any other medicine, with all the standard checks and balances Australians have come to expect.

 

In Australia, if a doctor is treating a patient who is likely to die in a matter of months, they can use the ‘Special Access Scheme Category A’ process to prescribe medicines that have not yet gone through all the standard checks and clinical trials we would normally require. We call these ‘unregistered medicines’ and almost all cannabis medicines currently sit in this category.

To prescribe unregistered medicines for less urgent cases, doctors can go through the ‘Category B’ process, which requires them to gain prior written permission from various Government bodies.

If a doctor chooses to prescribe an unregistered medicine through the ‘Category A’ process, they only need to submit a notification to the Federal Health Department within 28 days, retrospectively informing them of the treatment. The idea being that doctors would only do this if the benefits outweighed the risks, and people with a few months left to live shouldn’t have their medicines delayed by unnecessary paperwork. From June 13th 2017, doctors were able to do this with any unregistered medicine.

Except cannabis.

In November 2016, there was a prohibition created at the Federal level which made it impossible for doctors to prescribe cannabis through the ‘Category A’ process. No other drugs, no other substances. Just cannabis. That prohibition has now been removed.

To be fair, there may have been good reasons for this prohibition. But the only one I can think of is that there must be something systematically broken with our health regulations.

Either category A access is a fundamentally dangerous system which exposes patients to unacceptable and extreme risks and should be entirely removed, or the regulators have to finally admit they are quite prepared to maintain forms of cannabis prohibition despite the evidence and their own promises.

It’s one or the other.

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