By Partner, Dr Teresa Nicoletti and Paralegal, Helaena Short.
Bold claims have been made in the Daily Telegraph this morning that terminally ill patients will be given the “green light” to access medicinal cannabis products as of today. Unfortunately, the article grossly misrepresents the lawfulness of the supply of medicinal cannabis under the current framework. It instils unwarranted optimism for Australian patients on this topic.
Access to Medicinal Cannabis
Late last week, as the Huffington post published online, Labor leader Bill Shorten called on the Australian government to accelerate the rollout of medicinal cannabis products to patients.
Shorten was driven to contact Prime Minister Malcolm Turnbull over the matter after meeting Ben Oakley, a young Australian man suffering from the neurological condition, Stiff Person Syndrome. Oakley was previously able to access a medicinal cannabis product via the Special Access Scheme and his treatment, according to his father, “100% changed his life”. However, following the numerous legislative and regulatory amendments in 2016, Oakley, and patients like him, can no longer access the products they need.
The situation is created by a lag between the Australian government’s actions to legalise medicinal cannabis activities in Australia and the time it takes to legitimately begin cannabis cultivation, production and the manufacture of finished products containing cannabis, which can subsequently be supplied to patients.
In early 2016, both the Government and the opposition recognised that a large number of terminally ill Australian patients were already using medicinal cannabis products. 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. Subsequently, the landmark Amended Narcotic Drugs Act 2016 (Cth) was rapidly pushed through parliament in recognition of the widespread and immediate need for Australian patients to access, and continue to access medicinal cannabis products.
Despite such positive developments, recently the government has unconditionally restricted the access of terminally ill patients to any foreign medicinal cannabis products under Category A of the Special Access Scheme (SAS).
Under the Therapeutic Goods Act 1989 (Cth) all therapeutic goods are required to be approved and included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied unless there is an exemption. The SAS is one exemption pathway whereby a medical practitioner can provide an unapproved medicine to individual patients classified into Category A or Category B. Category A is for patients suffering from a terminal or life-threatening condition. Category B is for all other patients.
Supply to patients under Category A of the SAS does not require approval, or any other response from the Therapeutic Goods Administration (TGA) – therefore it is expeditious and efficient. Alternatively, supply under Category B requires TGA assessment and approval. For patients like Oakley, who are significantly suffering, the Category A process ensures timely access to effective therapy under the supervision of his dedicated medical practitioner.
However, the recently enacted Therapeutic Goods and Other Legislation Amendment (Narcotic Drugs) Regulation 2016 (Cth) excludes all medicinal cannabis products from Category A of the SAS. Therefore, 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.
As we discussed in a previous article, we believe this arbitrary exclusion is inconsistent with the rationale for Category A of the SAS, and means that terminally ill patients will be forced to endure extensive approval waiting times to access essential medicine(s) or resort to self-medication using illegally-obtained cannabis.
No other category of products (other than Schedule 9 prohibited substances) is excluded in this way. 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.
This morning, the Daily Telegraph published an article triumphantly suggesting that terminally ill patients would, “as of today”, be given the access they require. The article states that select companies (to be specified by Health Minister Greg Hunt later today) “will be permitted to apply to distribute cannabis oils and medications locally, establishing an immediate legal marijuana trade” (emphasis added). This is simply not correct.
The arrangement described in the Daily Telegraph enabling “importers [to] … source medicinal cannabis products from a reputable supplier overseas and store these in a safe, secure warehouse in Australia” (pending authorisation or approval to supply) is (and has always been) authorised under item 1 of Schedule 5A of the Therapeutic Goods Regulations 1990. However, in the case of cannabis, the act of importing a medicinal cannabis product, even if it is only for the purposes of interim storage until an authorisation or approval is granted, would be unlawful under the Customs (Prohibited Imports) Regulations 1956 without a licence and permit.
In any event, even if a licence and permit are granted, notwithstanding the announcement in the article, no real change has occurred which will facilitate access to medicinal cannabis products by patients in a way that is not already available. Although item 1(d) of Schedule 5A enables importation and storage of unapproved medicines “until they are dispensed…..for a Category A patient”, terminally ill patients (and all other patients) can access medicinal cannabis products by obtaining approval under Category B of the SAS or through an approved Authorised Prescriber.
The exclusion of medicinal cannabis products from Category A of the SAS remains in place and this is the only mechanism under the Therapeutic Goods Act and Regulations whereby terminally ill patients can access medicines “immediately” without any approval.
Causing Real Change
In the absence of any medical cannabis activities having commenced in Australia, it is unacceptable to force patients to resort to alternative access mechanisms (including, possibly, illicit access) until an adequate domestic supply chain is established. In this regard, we welcome the positive move by Senator Di Natale for the Greens to lodge a Motion to Disallow the exclusion of medicinal cannabis products from Category A of the SAS. We encourage the Senate to support this motion on 23 March 2017 to avoid any further disruption of these medicines to patients with demonstrated clinical need. If the motion succeeds, it will restore the ability for terminally ill patients to access imported medicinal cannabis products to relieve their immediate pain and suffering.
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