In February this year, Senator Richard Di Natale for the Greens lodged a motion to disallow (Motion) the exclusion of medicinal cannabis products from Category A of the Special Access Scheme (SAS) for unapproved medicines. The Motion, if successful, would have restored the ability for terminally ill patients to access imported medicinal cannabis products to relieve their immediate pain and suffering.
On 11 May 2017, however, the Senate’s decision was split 32/32 and as a result the Motion was unsuccessful. The outcome has enraged medicinal cannabis activists, who claim that the decision exposes an unfortunate side of One Nation and the Nick Xenophon Team members, who are willing to prioritise their political interests at all costs, even over the interests of terminally patients.
The division of the Senate votes on the Motion was particularly appalling considering the efforts of Pauline Hanson and the One Nation party to publicly express their support for the medicinal cannabis movement over recent months. Indeed, Queensland member Steve Dickson purportedly defected to the One Nation party for the primary purpose of facilitating access to medicinal cannabis. In the end, however, Labor and the Greens voted in favour of the Motion while the Coalition, One Nation, the Nick Xenophon Team and independent senators Cory Bernardi and Lucy Gichuhi voted against.
Di Natale expressed his frustration on twitter, stating: “It is so disappointing that these politicians couldn’t put the needs of terminally ill patients above political games.” Responses from the public understandably ranged from disappointed to scathing, demonstrating that the weight of public opinion is pushing for changes which facilitate access, not stifle it.
Senator Hanson responded on facebook by calling Di Natale’s Motion “cynical” and suggested that the disallowance would have “opened the floodgates and allowed massive unregulated, access to clinically unproven treatments.” Hanson went on to say:
“Imagine the opportunistic scammers who would have been waiting online to supply desperate Australian families with their watered down cocktail of hope if this change went through.”
In reality, such dramatised comments grossly underestimate the safeguards that are already in place to control access to unapproved medicines via Category A of the SAS and demonstrate that Hanson’s decision to vote against the Motion was based on her misinformed views about the operation of Category A of the SAS.
As we have previously discussed, the SAS is an exemption pathway whereby a medical practitioner can provide an unapproved medicine to individual patients classified into Category A or Category B. Supply to patients under Category A, that is patients suffering from terminal or life-threatening conditions, does not require pre-approval from the Therapeutic Goods Administration (TGA) – therefore it is expeditious and efficient. Schedule 1 (Part 1) of the Therapeutic Goods and Other Legislation Amendment (Narcotic Drugs) Regulation 2016 (Cth) (having commenced on 1 November 2016) arbitrarily excluded all medicinal cannabis products from Category A of the SAS (Medicinal Cannabis Exclusion).
It is important to understand that prior to obtaining any medicinal cannabis product (or other unapproved medicine) via Category A of the SAS, a medical practitioner must firstly be satisfied that a patient is “seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.” In this regard, the availability of Category A is already limited to only the most serious of cases.
Furthermore, a medicinal cannabis product accessed via Category A of the SAS would be sourced and prescribed by a medical practitioner for a patient who is under their direct supervision. In this regard, medicinal cannabis products would neither be purchased directly by patients or their “desperate” families, nor advertised to them online. The prescribing behaviours of doctors are strictly regulated by, inter alia, the Health Practitioner Regulation National Law, and the supply and advertisement of all medicines in Australia (including online) is regulated under the Therapeutic Goods Act 1989 (Cth).
In this regard, Hanson’s claims that disallowing the Category A exclusion of medicinal cannabis products would cause a “floodgate” effect and allow online “scammers” to take advantage of “desperate Australian families” are entirely misguided and unjustifiably alarmist.
Medicinal cannabis has been observed to assist Category A patients by providing symptomatic relief from some cancers, brain tumours, uncontrolled epilepsy, multiple sclerosis, chemotherapy-induced nausea and vomiting and chronic pain, which have not positively responded to other available therapies. Despite this, terminally ill patients are being forced to endure extensive approval waiting times to access essential medicine(s) or resort to self-medication using illegally-obtained cannabis.
In his address to the Senate, Di Natale said: “We have the coalition who says they want to cut red tape. Well, this is red tape they should be prepared to get the chainsaw out for and rip to shreds. This red tape is stopping a medication that relieves suffering getting into the hands those who need it”.
As a result of the tied vote on 11 May 2017, we must unfortunately confirm that the exclusion of medicinal cannabis products from Category A of the SAS remains in place. Furthermore, although there does not appear to be any practical reason why the Motion could not be moved again in a different context, the 15 day period for providing notice of a motion to disallow all or part of a specified legislative instrument has now passed. Accordingly, this avenue for a change to the Therapeutic Goods and Other Legislation Amendment (Narcotic Drugs) Regulation 2016 (Cth) is no longer available.
The Health and Life Sciences team at Mills Oakley continues to support all efforts by the Greens and the Labor party and, indeed, any other political faction which will facilitate access for all patients to medicinal cannabis in Australia. We hope that the next piece we write on this subject will be to update you on a step forward that reflects sensible decision-making which is based on informed opinions, so that the best interests of patients can be adequately met.
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