Australian doctors must jump through the hoops if they wish to prescribe medicinal cannabis. Alternatively, their patients can buy CBD oil at their local weekend market. Robin Osborne reports…
Various countries (notably Canada, and to an extent, Portugal and Peru) and a number of major US states have either legalized or decriminalised cannabis containing tetrahydrocannabinol (THC), the ingredient that will get you ‘high’. In other places, notably the UK, sellers and buyers of low-THC cannabidiol (packaged as CBD oil) are not liable for prosecution.
Reported New Scientist
https://www.newscientist.com/article/2172415-cannabis-oil-what-is-it-and-does-it-really-work-as-medicine/ the THC content of the CBD product must be below 0.2 per cent, making it “not psychoactive at this level,” in the words of neuropsychopharmacologist David Nutt from Imperial College London.
In Australia, despite widespread usage, the law’s attitude to psychoactive cannabis is clear, even if the penalties for holding small amounts for personal use have lessened over time: the drug is not legal.
More complex is the state’s attitude to the non-psychoactive and - depending on patients’ conditions, physiology, perhaps psychology and various other factors - potentially therapeutic CBD.
The Department of Health, which manages the Therapeutic Goods Administration (TGA), has invested considerable energy in the subject, and its web links make for interesting reading https://www.tga.gov.au/access-medicinal-cannabis-products-1
These include a list of approved manufacturers, suppliers and importers.
Perhaps most relevant here is that, “Australian registered medical practitioners who would like to access unapproved medicinal cannabis products for the treatment of appropriate patients outside of clinical trials may choose to do so through the SAS or the Authorised Prescriber Scheme.”
The ‘SAS’ is not a specialist military outfit but the Special Access Scheme, and the TGA informs us that this year it has approved 1771 SAS applications so far (to end October). The reasons included, but were not limited to, chemotherapy-induced nausea and vomiting, refractory paediatric epilepsy, palliative care indications, cancer pain, neuropathic pain, spasticity from neurological conditions, anorexia and wasting associated with chronic illness (such as cancer).
In January some 60 applications for “unapproved medicinal cannabis products” were approved. Throughout most of the year, and particularly recently, the number has been increasing exponentially.
This appears a high number, given that “it is expected that medical practitioners (prescribers) will have considered all clinically appropriate treatment options that are included in the ARTG [Australian Register of Therapeutic Goods] before applying to access an unapproved medicinal cannabis product under the SAS.”
In addition, as its name suggests, approval under this category is ‘special’, with the more usual approach being for a medical practitioner to seek to become an “Authorised Prescriber of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to specific patients (or classes of recipients) with a particular medical condition.”
To do so the medical practitioner must:
- have the training and expertise appropriate for the condition being treated and the proposed use of the product
- be able to best determine the needs of the patient
- be able to monitor the outcome of therapy.
At this time last year about 30 Australian doctors (of the approximately 43,400 GPs nationally) had been granted Authorized Prescriber status. The number has increased somewhat - perhaps to some hundreds - as a result of publicity, patient pressure and, not least, mounting evidence that CBD is actually effective for some conditions in some people.
In this context, more doctors are showing a willingness to undertake the ‘training’ required by the TGA. Most seem to feel the process is onorous.
Noting that in the USA cannabidiol has been lumped together with recreational cannabis - legal or illegal, depending on the state - New Scientist suggested the tide may turn after a recent WHO review concluded that cannabidiol “exhibits no effects indicative of any abuse or dependence potential” but “has been demonstrated as an effective treatment of epilepsy … and may be a useful treatment for a number of other medical conditions.”
Efficacy aside, it is worth noting that medical opinion agrees it is not possible to overdose on cannabis, either the THC or CBD variants, although high level usage of the former is best avoided by those with mental health issues or personality disorders, while smoking anything is deleterious to one’s health.
Amidst this convoluted and at times complex debate, there is one major anomaly: CBD oils (and creams) are displayed and sold openly and presumably legally at stalls in a number of local Northern Rivers markets. The products, ranging in price from $30.00 (10ml) to $175.00 (100ml) are refined from low-THC hemp grown and processed organically on a property near Lismore.
It is understood that samples from each crop are sent to Southern Cross University for verification of the ‘Low THC’ status (nil THC is not possible) that is marked on the labels. The bottles also state ‘Not to be taken internally’.
A similar warning, advising against human consumption, was long attached to the (low THC) hemp seeds processed at a Bangalow factory, until regulations changed last year and the product, claimed to be highly nutritious, could be marketed as a ‘food’. The move, which saw the business grow, was welcomed by local MPs because of the boost to local employment.
While a very different product, CBD oil may well emulate the hemp seeds journey in the future, the question being how long before it is classed as a ‘medicine’, albeit not the miracle one many might wish for.