Explainer: medical cannabis news in NSW - August 2016

July media wrap up: is medical cannabis legal in NSW?

In July, some interesting cannabis research was published, including a study in the Journal of American Heart Association that suggests second-hand cannabis smoke impairs cardiovascular function. But the real cannabis news came in quietly, over the weekend, as the month was drawing to a close.

Usually our media wrap up covers a range of different media stories from the month, but as none made a splash quite like the NSW medical cannabis legislative changes, the July media wrap will focus solely on this one issue.

NSW granted licence to grow medical cannabis

In July, NSW secured a licence from the Federal Government to grow cannabis for medical use in Australia. This is the first licence given the thumbs up since the Federal Government changed legislation earlier in the year, paving the way for licenced, regulated grows within our country.

At the time, there was some confusion about what the Federal changes meant is medical cannabis legal? Can anyone get a licence? Can we grow at home?

The Government worked to allay some of the confusion, confirming medical cannabis sales remain illegal, Australia isn’t becoming the home of the marijuana outlets we see dotting the streets of Colorado, and growing your own most definitely is still prohibited. With this cleared up, things remained fairly quiet for a while as different organisations (and whole states) prepared their applications for licences.

New South Wales legalises prescription of cannabis and cannabis-based medicines

New South Wales licence to grow cannabis for medical use was granted in late July, and it seemed that would be the big cannabis news of the month. But on the last Saturday of the month, morning news buzzed with the announcement that changes in NSW would come into practice straight away which would enable doctors to prescribe cannabis and cannabis-based medicine to patients.

Who can prescribe cannabis and how can you get it?

Details about the change have seemed a little scarce and the media (like many people) largely uninformed about the implications of these changes. This has resulted in a lot of confusion in the community who can obtain a cannabis prescription? What illnesses or symptoms are included? Is it only medicines like Sativex that can be prescribed, or can a patient receive a prescription for bud to smoke, vaporise or eat?

The change in NSW practice is underpinned by the Poisons and Therapeutic Goods Amendment (Designated Non-ARTG Products) Regulation 2016, which came into effect on 1 August 2016. The amendment allows doctors to apply to NSW Health for permission to prescribe cannabis-based products that are not on the Register of Therapeutic Goods.

Once the prescribing doctor has successfully applied for their Authorised Prescriber status they will need to apply for permission to prescribe for each patient. Along with the application form, doctors will need to include clinical evidence supporting their proposed use of the product, and must have already tried existing first-line treatments with the patients for whom they hope to prescribe cannabis.

What this means is that patients should not be able to head to the doctor with a trivial or transient condition, such as a headache, demanding cannabis, as is the case in USA the doctor has to try other treatments first and have evidence to support prescribing cannabis for the particular symptom or disorder.

If you’re unsure of which illnesses have clinical evidence to support the use of cannabis, check out our research centre. If your illness isn’t there, let us know and we’ll look into it.

The other hoop to jump through in the application is manufacture and quality of the product. The doctor must be able to obtain the product legally and it must be of an acceptable standard according to the TGA. While plant materials (like bud for smoking) are on the list of cannabis products doctors can seek permission to prescribe, none is legally grown in Australia yet, and products must be legally obtained which creates some challenges.

The NSW Government Health website states:

Applications to prescribe are not limited to such [pharmaceutical preparations] products; however the product applied for must be legally produced and manufactured to appropriate quality standards with evidence supporting use of the particular product for the relevant patient.

There are currently no cannabis products lawfully manufactured in Australia, but the Commonwealth can in future potentially license cultivation, production, manufacture and supply of cannabis and its products for therapeutic use. A NSW based manufacturer must also hold a licence issued by NSW Health.

Breaking it down

While more information will no doubt become available in coming days and weeks (and we’ll absolutely keep you updated), so far, what is available suggests:

If your aim is to get a prescription for cannabis or a cannabis-based product:

• Your doctor will need to apply to the TGA and NSW Health for approval to prescribe cannabis.
• You will need to have failed to get relief from other first line (evidence-based) treatments before trying cannabis.
• Your doctor will need to support his/her application with clinical evidence showing the benefit of the product for treatment of the illness/symptom.
• The dispensing pharmacy will need to apply for approval to dispense cannabis.
• The product will need to be manufactured and obtained legally.
• The product will need to be of a standard that meets the relevant TGA regulations.
• Cannabis products aren t subsidised.
• Cannabis for medical purposes is currently not legally grown in Australia.

What is not yet clear:

• Will you be able to obtain exemption from workplace and roadside cannabis testing if using prescribed cannabinoids?
• Will there be a limit on dose or prescription duration?
• What contraindications might apply e.g. other conditions such as schizophrenia for THC dominant products, pregnancy etc?
• Will pharmacies be required to dispense all forms of cannabis?
• Will there be a dedicated monitoring system for adverse events at state and or federal level?

NCPIC will continue to update this information as more details are revealed.