The Department of Health has taken the unusual step of publishing a direct rebuttal to an article published in the Australian Financial Review on 4 December 2016. The article reported that Ecofibre, a cannabis grower backed by Barry Lambert and Chris Cuffe, has abandoned efforts to grow medicinal cannabis in Australia and will instead do so in the US.
We support the Department’s rebuttal, because the article repeats several misconceptions regarding the requirements for obtaining a licence to grow or produce medicinal cannabis. For example, contrary to the claims contained in the article, it is not true that medicinal cannabis crops may only be grown in “costly high-security greenhouses”, and while it is true that cultivators must nominate a particular manufacturer they will be supplying, that manufacturer is not required to specify particular approved users in advance.
The assertion in the article that it is “bizarre” that additional restrictions apply to the cultivation of low-THC cannabis for medicinal purposes, compared to when the same strain is grown for food or fibre, fails to recognise that Australia has various obligations under the UN Single Convention on Narcotic Drugs (Single Convention) – importantly, these obligations do not apply in respect of cannabis grown exclusively for industrial or horticultural purposes, but do apply in respect of medicinal cannabis. The cultivation of medicinal cannabis, whether it is low-THC cannabis or not, has not been lawful in Australia until now, and a new licensing regime with additional restrictions was always going to be necessary in light of Australia’s international obligations.
The requirements of the Single Convention mean that medicinal cannabis regulation must balance the interests of patients against the need to prevent stockpiling and diversion of cannabis for illicit use. Accordingly, while the requirements for obtaining a medicinal cannabis cultivation or production licence may be regarded by some stakeholders as onerous, they are certainly not insurmountable. We have previously published guidance in this area here, here and here, and are assisting a number of clients who do intend to apply for licences and cultivate and produce medicinal cannabis under the new regime.
Access to medicinal cannabis
The statements in the AFR, although inaccurate in certain respects, are understandable in others. There is significant and increasing general interest in medicinal cannabis, which has been further encouraged by the recent relaxation of cannabis prohibition in other jurisdictions – particularly in various US states. Perhaps unsurprisingly in that context, media coverage of the new Australian regime has presented it as akin to “legalisation” of medicinal cannabis. However, it is likely that prospective medicinal cannabis industry participants, medical practitioners, and patients with an expectation of more unfettered access to medicinal cannabis, will be disappointed by what is turning out to be a very complex regulatory framework.
The AFR article claims that “it is almost impossible to get permission to use cannabis”. In response, the Department has stated that “under Commonwealth legislation, it has been possible for many years for patients to access medicinal cannabis products”, and that “the use of medicinal cannabis can be approved in all Australian states and territories.” Both of these statements are true, but one of our frustrations is that under the new Commonwealth and State legislation, medicinal cannabis products are subject to unique restrictions which do not apply to any other medicines in Australia.
Broadly speaking, the question of whether a therapeutic good can be supplied in Australia is one determined at a Commonwealth level by the TGA and by the States/Territories depending on the scheduling status of the good being supplied. However, we note that a number of States have imposed additional legislative requirements on supply that only apply to medicinal cannabis products. We have previously expressed concern, for example, about apparent double-regulation in Queensland, where doctors and patients will need to obtain approvals at both a State and Commonwealth level for the use of medicinal cannabis products.
In addition, the Commonwealth Government has very recently closed off one of the previously existing avenues for accessing medicinal cannabis products under Category A of the Special Access Scheme, which provides a mechanism for terminally ill patients to obtain access to unapproved drugs with appropriate certification from their doctor. The rationale for the scheme – as stated by Senator Tate in 1991, and cited by the TGA – is that “when people are confronting the certainty of death and have a terminal or life-threatening illness, special provisions clearly ought to be made to help them psychologically face that prospect by giving them assurance that virtually whatever they wish, by way of administration of a drug of which they have learnt, can be undertaken.”
However, the recently enacted Therapeutic Goods and Other Legislation Amendment (Narcotic Drugs) Regulation 2016 (Cth) (Regulations) operates to exclude all medicinal cannabis products from Category A of the Special Access Scheme. No other category of products (other than Schedule 9 prohibited substances) is excluded in this way. Under the new Regulations, patients who have previously been permitted to import certain medicinal cannabis treatments (e.g. dronabinol, a treatment for chemotherapy-induced nausea which has been available since the 1990s) under the scheme will no longer be able to do so.
In our view, this arbitrary exclusion is inconsistent with the rationale for the Category A Special Access Scheme, and means that terminally ill patients will be forced either into potentially lengthy and complex Commonwealth and State approvals processes, or to self-medication using illegally-obtained cannabis. In this respect, we note that just last year the NSW Government introduced the Medicinal Cannabis Compassionate Use Scheme, under which police have the discretion not to charge terminally ill adults who use cannabis to alleviate their symptoms.
The supply of therapeutic goods in Australia is subject to many safeguards, which operate appropriately even in respect of Schedule 8 substances with a high potential for abuse. No adequate explanation has been given for why that same system cannot be applied to medicinal cannabis products.
When the Commonwealth medicinal cannabis licensing scheme was passed, Sussan Ley, the Minister for Health, acknowledged “an historic day for Australia and the many advocates who have fought long and hard to challenge the stigma around medicinal cannabis products so genuine patients are no longer treated as criminals,” and claimed patients would now see “seamless access to locally-produced medicinal cannabis products from farm to pharmacy.”
There is no doubt that the past year has seen important steps taken in this area. However, Australian patients, industry stakeholders and the public in general are entitled to raise questions as to why medicinal cannabis is treated, in a number of respects, so differently from other therapeutic goods. As further clinical trials are conducted and clinical experience with these products improves, we expect (and will continue to advocate for) a regulatory regime that treats medicinal cannabis products the same way as any other therapeutic goods in Australia.