Chapter 2Views on the bill
2.1This chapter examines the key views raised by submitters to the committee’s inquiry into Improving Access to Medicinal Cannabis Bill 2023 (the bill).
2.2It begins by reviewing concerns raised by submitters in relation to a lack of evidence that supports down-scheduling medicinal cannabis products in the Poisons Standard. It considers the effectiveness of the Authorised Prescriber Scheme (APS) and the Special Access Scheme (SAS) pathways in providing medicinal cannabis products to patients and explores the impacts of the bill’s provisions in relation to these schemes.
2.3The chapter then examines additional barriers to medicinal cannabis access, namely cost and state and territory drug-driving laws, and briefly considers certain legislative concerns associated with the bill. The chapter concludes with the committee’s view and subsequent recommendation.
Overview
2.4Submitters generally supported the intent of the bill and the use of medicinal cannabis. However, submitters noted that the provisions of the bill would not achieve its objective of improving access to medicinal cannabis.
2.5Mills Oakley, a national law firm, submitted:
We want to make it very clear that we are the strongest proponents of improving access to medicinal cannabis products – it has been a focus of our work in the medicinal cannabis industry since legalisation. However, to put it mildly, we consider that the Bill is misguided and misinformed, and will do nothing in reality to improve access.
2.6Medicinal Cannabis Industry Australia stated that the intent of the bill:
…to improve access for patients and thus alleviate pressures on both patients, doctors and pharmacists, is commendable. However, MCIA does not believe that the Bill as it stands addresses the key impediments to patient access.
2.7The Australian Pain Society commented:
[we appreciate] the intent of this Bill, however, there remains insufficient evidence for therapeutic support in the area of pain management and uncertainty as to how the rescheduling would allow for better access. At this time, we are not supportive of this Bill.
Lack of evidence and data
2.8As explained in Chapter 1, this bill seeks to amend the Poisons Standard to down-schedule medicinal cannabis products to improve the availability of these products for the general population.
2.9However, several submitters raised concerns that there is a lack of existing evidence that justifies the down-scheduling of medicinal cannabis products to enable wider access. For instance, the Royal Australian and New Zealand College of Psychiatrists (RANZCP) acknowledged interest from both the medical profession and the general public in medicinal cannabis. Yet, they submitted that evidence of efficacy and safety of medicinal cannabis products is limited. Consequently, RANZCP commented that they do not support the provisions of the bill until further evidence of the benefits of medicinal cannabis is generated.
2.10Similarly, The Faculty of Pain Medicine, Australian and New Zealand College of Anaesthetists, stated that the most common reason to prescribe medicinal cannabis is to treat chronic pain. However, the organisation advised that it does not support the use of medicinal cannabis to treat chronic pain outside of clinical trials due to the lack of evidence that support its benefits, as well as the unknown health effects of the formulations.
2.11Some submitters cautioned that the bill’s provisions bypass important processes associated with scheduling decisions. In particular, the Department of Health and Aged Care (the Department) flagged that:
The proposed amendments in the Bill…do not appear to be based on the detailed evidential analysis ordinarily conducted for scheduling decisions.
2.12Submitters identified issues that could arise from making scheduling decisions without sufficient supporting evidence. For instance, The Australian Pain Society noted that there are currently no formal accredited and standardised training courses on prescribing medicinal cannabis products due to a lack of evidence.
2.13Thus, the Australian Pain Society argued that:
the re-scheduling of medicinal cannabis to Schedule 4 for any medical practitioner to prescribe would put undue pressure on medical practitioners to consider prescribing low evidence based medicinal cannabis for which limited information and no recognised prescriber training is available concerning clear indication for use, dosage to treat and dosage to minimise side effects.
2.14Submitters also discussed another intention of the bill, which is to enable down‑scheduled medicinal cannabis products to be included on the Pharmaceutical Benefits Scheme.
2.15Both the Australian Medicinal Cannabis Association and United in Compassion noted that the Pharmaceutical Benefits Scheme (PBS) requires high levels of evidence to support listing, which is not currently available for medicinal cannabis products. Similarly, Mills Oakley noted that the current scheduling of medicinal cannabis products is not the reason that these products are not listed on the PBS. Instead, they stated that:
…there is limited scientific evidence to support the use of medicinal cannabis products for most indications, such that it is unlikely that a company seeking to list a medicinal cannabis product on the PBS will have the requisite data to demonstrate its comparative effectiveness and cost. This problem is not ameliorated by rescheduling medicinal cannabis products…
The Approved Prescriber Scheme and the Special Access Scheme
2.16The bill’s explanatory memorandum states that the bill’s provisions are intended to remove the need for practitioners to use the Authorised Prescriber Scheme (APS) and the Special Access Scheme (SAS) for medicinal cannabis. The bill seeks to achieve this by down-scheduling these products to Schedule 4, with the intent of allowing any medical practitioner to prescribe medicinal cannabis, and consequently restoring the primacy of the doctor/patient relationship.
2.17The Australian Lawyers Alliance noted that these two schemes act as institutional and administrative barriers for patients who wish to access medicinal cannabis. Additionally, Medicinal Cannabis Industry Australia recognised that the schemes can be a burden to prescribers, which can further impact patients. Alternatively, the Medicinal Cannabis Association contended that the schemes are effective, citing that since 2016, 1,157,195 patients have accessed medicinal cannabis via the APS, and 344,695 accessed products via the SAS-B pathway.
2.18However, Mills Oakley noted that most medicinal cannabis products are not registered on the Australian Register of Therapeutic Goods (ARTG). They explained that as a result, these products can generally only be prescribed via the SAS and APS. In this context, the Department highlighted that down‑scheduling medicinal cannabis products in the Poisons Standard will not remove the need for practitioners to prescribe most medicinal cannabis via the SAS and APS. They explained that products which are not on the ARTG, which includes most medicinal cannabis products, still need be accessed via these schemes, and that the bill’s down-scheduling provisions would not change this.
Other barriers to access – costs and state laws
2.19The bill’s explanatory memorandum purports to reduce costs associated with medicinal cannabis by rescheduling cannabis to Schedule 4 of the Poisons Standard, thereby seeking to list medicinal cannabis on the PBS as a separate process.
2.20Submitters were generally supportive of the proposed PBS listing. Individuals with lived experience raised that the costs associated with accessing medicinal cannabis acted as a barrier, with one submitter stating:
When you have two adults both of whom are prescribed cannabis oil and are seeing the doctor, this becomes expensive. I believe it is the biggest expense outside of our mortgage.
2.21Another submitter discussed her experience with endometriosis, arguing that:
Cannabis is a safe and effective pain management tool that few endometriosis patients can access due to it not being on the PBS…Having it on the PBS would mean so many of us can choose to taper off opiates and take a safer medicine…
2.22However, some submitters such as Mills Oakley, noted that the bill’s provisions would not enable listing of medicinal cannabis on the PBS, thereby not reducing costs. While United in Compassion commented that there is no legislative requirement for a medicine to be listed on the ARTG to be included on the PBS, the Department clarified that as a matter of policy, products are generally only listed on the PBS if they are on the ARTG, regardless of scheduling status:
As the scheduling of a substance has no bearing on the eligibility of a product containing that substance to be listed on the PBS, the rescheduling of cannabis proposed in the Bill would not of itself allow for the inclusion of medicinal cannabis products on the PBS.
2.23The Australian Medicinal Cannabis Association similarly acknowledged that cost and affordability are major barriers to access, but echoed concerns that the bill would not achieve its objectives:
The proposed amendments…although proposed with good intent, will not address the main aim of the Bill of Improving Access, because they will not enable PBS listing, nor address the key barrier, which is the cost to patients.
2.24Other than the cost of medicinal cannabis, United in Compassion argued that an obvious barrier to patient access are existing state and territory drug‑driving laws. The Australian Medicinal Cannabis Association explained that these laws discriminate against patients who drive with any legally prescribed detectable level of THC. The Australian Alcohol and other Drugs Council (AADC) and Mills Oakley commented that existing drug-driving laws consequently act as a deterrent for people seeking a prescription, due to the risk of engagement with the criminal justice system. As a result, AADC argued that any legislative changes to medicinal cannabis access would also necessarily involve commensurate amendments to these driving laws. The bill’s provisions, as per Schedule 1, do not provide an avenue for such reforms to occur.
Legislative concerns
2.25The Department raised certain legislative concerns regarding the bill’s provisions, stating that although the Legislation Act 2003 (the Legislation Act) enables acts to amend legislative instruments (which the Poisons Standard is), the Legislation Act also ensures that the amended instrument can be subsequently amended or repealed. The Department noted that if the bill was enacted:
It would be open to the Secretary (or their delegate) to amend, or repeal and replace, the Poisons Standard (as amended by the Bill) as appropriate.
2.26The bill, if enacted, would amend the February 2023 iteration of the Poisons Standard. However, at the time of writing, the February iteration is no longer in force and has been superseded by the current iteration, which is the Therapeutic Goods (Poisons Standard–July 2023) Instrument 2023.
2.27The Department advised that it anticipated that the February 2023 PoisonsStandard would likely be updated by the time the bill would be enacted, noting that it is repealed and replaced approximately three times per year. The Department explained that if the bill does not refer to the current iteration of the Poisons Standard at the time the bill was to become law, or if it does not account for future revisions to the legislative instrument, the bill may not have any practical effect.
Committee view
2.28The committee thanks the individuals and organisations that provided a submission to the inquiry for their views and recommendations on the bill, and more broadly, for their general insights into medicinal cannabis access in Australia.
2.29The committee appreciates the bill’s intention to improve access to medicinal cannabis. However, the committee also recognises the concerns raised by submitters that they do not support the bill due to safety concerns, and that the bill will not achieve its desired outcome of enabling better access to medicinal cannabis.
2.30The committee is persuaded by submitters that down-scheduling medicinal cannabis products on the Poisons Standard would be imprudent, as this change is not supported by enough data, and would consequently bypass the important scheduling process that is undertaken by the Secretary of the Department.
2.31The committee also notes that this lack of evidence acts as a barrier to the listing of medicinal cannabis products on the PBS, which therefore stymies the bill’s intent of creating an avenue for the listing of medicinal cannabis products on this scheme.
2.32The committee acknowledges that it received competing views on the APS’s and SAS’s efficacy in providing patients with access to medicinal cannabis products. However, the committee received compelling evidence that the bill would not remove the need for practitioners to prescribe via the APS and SAS.
2.33The committee acknowledges that this is because most medicinal cannabis products are not listed on the ARTG, and consequently must be accessed via these schemes, regardless of their scheduling status in the PoisonsStandard.
2.34Additionally, in the committee’s view, the bill and its provisions do not adequately address two of the major barriers to access, as identified by submitters: cost and state laws. The committee received persuasive evidence that the bill would not enable medicinal cannabis to be listed on the PBS and therefore would not reduce costs. Further, the committee notes that the bill’s provisions do not seek to address state and territory drug‑driving laws.
2.35The committee further acknowledges that the bill, as it stands, may not have any practical effect as it does not refer to the current iteration of the PoisonsStandard, or account for future revisions to this legislative instrument.
2.36The committee recognises the intent of the bill. However, the committee notes that the bill’s provisions will not achieve its desired outcomes. Consequently, the committee recommends that the bill not be passed.
2.37The committee recommends that the bill not be passed.
Senator Marielle Smith
Chair