On 12 April 2016, the Victorian Parliament passed the Access to Medicinal Cannabis Bill 2015 (Vic) (Bill) to much fanfare, lauding it as an Australia-first historic move that will enable Victorian patients and their families to legally access medicinal cannabis in exceptional circumstances. The Bill delivered on an important election promise of the Victorian Labor Government and was introduced with the primary intention of allowing a clinical trial of medicinal cannabis in children suffering severe epilepsy to begin in Victoria in early-2017.
However, the impact of the Access to Medicinal Cannabis Act 2016 (Vic) (AMCA), which is not due to commence operation until day(s) which are yet to be proclaimed (but no later than 1 February 2017), is likely to be significantly curtailed by recent amendments introduced into the Commonwealth Narcotics Drugs Amendment 1967 (NDA) by the Narcotic Drugs Amendment Act 2016 (Cth) (NDA Amendment Act), which will come into effect no later than 30 October 2016. The AMCA is also likely to be affected by unresolved issues regarding its interaction with the existing Commonwealth framework for the regulation of therapeutic goods.
In light of these issues, despite the wave of positive publicity surrounding the reforms, a critical review of the AMCA suggests that its practical effect will be more in the order of a political win for the Victorian Labor Government rather than enabling Victorian patients to access quality medicinal cannabis products.
Framework under the AMCA
Cultivation of cannabis and manufacture of medicinal cannabis products
The Bill originally provided a scheme whereby licences could be obtained to cultivate cannabis or to manufacture medicinal cannabis products. However, the Legislative Council’s significant amendments to the Bill included removing the entire cultivation licensing scheme from the AMCA in recognition of the fact that the NDA will, on the commencement of the NDA Amendment Act, enable the Commonwealth to grant cultivation licences for cannabis and render void any State or Territory legislation which purports to do the same.
Therefore, the AMCA as passed by both Houses authorises the Secretary of the Victorian Department of Economic Development, Jobs, Transport and Resources (Resources Secretary) (or third parties contracted by the Resources Secretary) to cultivate cannabis in accordance with a Commonwealth approval issued under section 25A of the NDA, to obtain cannabis from a cultivator holding a Commonwealth licence or “any other prescribed person or body”, to manufacture intermediate cannabis products for the purpose of research or manufacture of medicinal cannabis products, and to supply cannabis or intermediate cannabis products to the Secretary of the Victorian Department of Health and Human Services (Health Secretary) or manufacturers licensed under the AMCA. Private entities wanting to cultivate cannabis in Victoria will, therefore, either need to be contracted by the Resources Secretary to cultivate on its behalf or wait until the Commonwealth scheme commences by no later than 30 October 2016.
The AMCA provides that the Health Secretary can manufacture medicinal cannabis products and, importantly, grant licences to third parties to manufacture medicinal cannabis products. However, as currently drafted, the AMCA appears to place significant restrictions on the granting of manufacturing licences by, for example, requiring applicants to already hold a Commonwealth manufacturing licence. This would appear to create a burdensome overlap in regulatory requirements and, in particular, it seems that this would effectively require an applicant to satisfy both a Commonwealth and a Victorian fit and proper person test.
Sale and supply of medicinal cannabis products
Any medicinal cannabis products manufactured pursuant to a manufacturing licence are only able be sold or supplied to the Health Secretary, who is then authorised under the AMCA to “approve” the medicinal cannabis product (unless it is designed to be administered by smoking) “if satisfied that the product is of sufficient standard and quality to be suitable for use by patients in accordance with [the ACMA]”. Any product so approved will be added to an “approved medicinal cannabis product register” administered by the Health Secretary.
In our view, this appears to be a significant encroachment into the regulatory space currently occupied by the Therapeutic Goods Administration (TGA) which, as delegate of the Secretary of the Federal Department of Health, is responsible for regulating the quality, safety and efficacy of therapeutic goods and approving them for supply on that basis (unless they are exempt goods for which an approval is not required).
Once the Health Secretary has “approved” a medicinal cannabis product, it is authorised to supply that product to authorised research practitioners or Victorian pharmacists. Pharmacists are, in turn, only authorised to sell or supply the product to a patient holding a “patient medicinal cannabis authorisation” (Patient Authorisation) for that product.
Notably, only a medical practitioner holding a “practitioner medicinal cannabis authorisation” (Practitioner Authorisation) granted by the Health Secretary is authorised to issue a Patient Authorisation. In this regard, the AMCA currently provides that Practitioner Authorisations may only authorise the medical practitioner to issue Patient Authorisations:
- to “eligible patients”, who are currently defined as patients under 18 years of age who experience “severe seizures resulting from an epileptic condition in respect of which other treatment options have not proved effective or have generated intolerable side effects”; or
- to patients who are to participate in research or a trial; or
- in exceptional circumstances, to patients who are not “eligible patients”.
The Health Secretary will, in addition to the above, have the ability to set a maximum price at which pharmacists may sell the medicinal cannabis products to patients and also supply medicinal cannabis products to medical practitioners holding Practitioner Authorisations authorising them to issue Patient Authorisations to participants in research or a trial.
As will be immediately apparent to anyone with an understanding of Australia’s world-class regulatory regime, the Prescriber Authorisation scheme under the AMCA significantly overlaps with the authorised prescriber and special access schemes, and clinical trial exemptions, for unapproved therapeutic goods provided under the Act and it is presently unclear how these schemes will operate concurrently in practice. In this regard, on the Second Reading of the Bill in the Legislative Council, the Honourable Mary Woolridge stated that:
“Victoria is seeking an exemption from the commonwealth (sic) from medicinal cannabis having to be engaged with the TGA processes. My understanding is that the request for such an exemption has been rejected.”
Ms Wooldridge noted that, in the event that this exemption is not granted, a patient holding a Patient Authorisation will still be unable to access the medicinal cannabis product unless they, or their medical practitioner, has also complied with one of the access schemes for unapproved goods provided under the Act (e.g. the special access scheme). This would, in effect, increase the restrictions on supply of medicinal cannabis products in Victoria.
Victoria’s push to sit outside the Commonwealth framework is further reinforced by provisions of the AMCA which remove medicinal cannabis from Schedule 9 of the Victorian Poisons Code (Code) and place it in a purpose-made Schedule of the Code to allow the imposition of the additional restrictions discussed above. Notably, these provisions pre-empt the likely rescheduling of cannabis and certain botanically-derived cannabis extracts from Schedule 9 to Schedule 8 of the Poisons Standard (SUSMP), which was considered by the Advisory Committee on Medicines Scheduling and Advisory Committee on Chemicals Scheduling at its March 2016 meeting, by including a clause excluding those substances from Schedule 8 of the Code which could be enacted by proclamation in the event that the SUSMP is amended.
In our view, moving away from a nationally uniform scheme is more likely to hamper, rather than facilitate, access to medicinal cannabis products by Victorian patients.
Having regard to the strict Government oversight of the scheme, it appears that the primary purpose of the AMCA, in addition to fulfilling the Labor Government’s election promise, is to give Victoria a modest head start over other States and Territories in the cultivation of medicinal cannabis, with a view to enabling the clinical trial use of medicinal cannabis products in children with epilepsy to commence in early 2017.
However, in our opinion, if the AMCA continues to operate in its present form once the Commonwealth scheme comes into effect under the NDA, Victoria risks being left behind by imposing additional restrictions on the supply of medicinal cannabis products that go beyond the restrictions that apply under the Commonwealth regulatory framework for therapeutic goods.
In this regard, we note with concern that the Public Health (Medicinal Cannabis) Bill 2016 (Qld) (PHMC Bill), which was introduced into the Legislative Assembly of Queensland on 10 May 2016, contains similar restrictions on supply to the AMCA, potentially signalling a trend towards this additional regulation by the States and Territories.
Therefore, although we commend the push towards providing access to high quality, safe and efficacious medicinal cannabis products to patients in need, we are of the view that the AMCA is unlikely to have the desired practical effect, particularly if other States and Territories follow suit and impose their own similar, but not identical, access schemes.