Mills Oakley partner Dr Teresa Nicoletti and lawyers Ella Adams and Rebecca Pecovski ponder what One Nation’s new medicinal cannabis access bill would mean for patients if it becomes law.
Earlier this month, One Nation leader Pauline Hanson introduced the Improving Access to Medicinal Cannabis Bill 2023 in the Senate. The explanatory memorandum accompanying the bill states that it proposes to:
- reschedule medicinal cannabis to schedule 4, allowing its prescription by any medical practitioner;
- adopt a definition for cannabis that allows a higher level of THC, up from 0.1% to 1%, which its authors say is below the recognised level for any hallucinogenic response and harmonises Commonwealth law with state and territory laws;
- allow whole-plant cannabis products with a limit of 1% THC and 10% CBD to be sold over the counter at a chemist or by a veterinarian to persons over 18; and
- retain the listing for hemp as a food product with existing limits unchanged.
According to the memo, these proposed changes supposedly:
- remove the need for the Approved Prescriber Scheme (APS) and Special Access Scheme (SAS) to access medicinal cannabis; and
- allow for the inclusion of medicinal cannabis products on the Pharmaceutical Benefits Scheme (PBS).
The aim of the bill is to improve access for all Australians and for animals. But does it achieve its intended purpose?
The Poisons Standard
Poisons and medicines are categorised into different schedules, which are set out in the Poisons Standard depending on their intended use(s) and potential for harm.
Different levels of control apply to the different schedules with respect to how a substance is labelled, sold, bought, stored and disposed of. The lower the schedule, the less stringent the control.
Most cannabis products are schedule 8 substances, with those containing predominantly CBD listed in schedule 4.
Scheduling decisions involve a risk-benefit consideration, which involves taking into account factors such as:
- the toxicity of the substance;
- the purpose of use (including the diagnostic decision);
- potential for abuse and misuse;
- safety in use, including the need for specialist training or personal protective equipment; and
- the benefits/needs of access to the substance.
There is no evidence that these factors were considered in the drafting of the bill, which proposes to amend the Poisons Standard so that medicinal cannabis products currently in schedule 8 are down scheduled to schedule 4.
Although the proposed amendments would decrease the regulatory burden relating to the labelling, storage, sale, supply and disposal of medicinal cannabis products, the down scheduling would have no bearing on the requirement for prescribers to obtain approval or authorisation to supply medicinal cannabis products under the SAS and APS, or on the potential for them to be reimbursed under the PBS.
This is because medicinal cannabis products, in the main, are not registered in the Australian Register of Therapeutic Goods (ARTG).
Accessing unapproved medicinal cannabis products
Therapeutic goods are registered by the Therapeutic Goods Administration (TGA) following an assessment which has established that their quality, safety and efficacy is satisfactory.
The pathway to registration in the ARTG is an onerous one, requiring the submission of a complex dossier of clinical, preclinical, chemistry and manufacturing data to the TGA.
The investment required to prepare such a dossier is prohibitive and costly, and is further complicated in the case of medicinal cannabis products by the relatively limited scientific evidence regarding their efficacy for most indications.
As a result, there are only two medicinal cannabis products currently registered in the ARTG, being Sativex and Epidyolex.
Regardless of whether a product is classified as a schedule 4 or schedule 8 medicine, medical practitioners are not lawfully able to prescribe unapproved medicinal cannabis products other than in accordance with the SAS or APS, or pursuant to a clinical trial that has been approved by a human research ethics committee.
We therefore do not see how the bill, as drafted, would possibly obviate the need for the SAS and APS.
Issues hampering access to medicinal cannabis
We do not agree that the existing scheduling framework combined with the SAS and APS frameworks is preventing Australians from accessing medicinal cannabis.
While there are additional controls placed on schedule 8 medicines compared with schedule 4 medicines, broadly speaking, every patient seeking access to a medicinal cannabis product for a legitimate therapeutic purpose is able to obtain it.
If anything, the additional controls have some bearing on the administrative red tape affecting the cost of supply, but access per se is not materially affected by a medicine’s scheduling.
In terms of access to medicinal cannabis, we note that the TGA reported that between July 2016 and July 2022, 1,157,195 patients were able to access medicinal cannabis through the APS, and 344,695 SAS-B applications were approved.
The issues concerning access to medicinal cannabis products relate to their, at times, prohibitive cost. Access is also undermined by the existing state and territory drug-driving laws that, in effect, cause patients with a legitimate need for medicinal cannabis to decline treatment because of fear of retribution under what we regard as archaic laws which ought to have been amended when medicinal cannabis was first legalised in 2016.
While we are of the view that more affordable medicinal cannabis products would undoubtedly make such medicines more accessible, we do not agree that the proposed amendments to the Poisons Standard will facilitate listing on the PBS.
Applications for PBS listing require the preparation of detailed submissions that are reviewed by the Pharmaceutical Benefits Advisory Committee (PBAC), who make recommendations to the Minister for Health and Aged Care as to which medicines should be subsidised.
In making such recommendations, the PBAC must consider the effectiveness and cost of therapy involving the use of the drug, which is usually established by comparing it with alternative therapies currently listed on the PBS.
As noted, 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 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 from schedule 8 to schedule 4 – in fact, the scheduling of a medicine has no bearing whatsoever on its suitability to be listed on the PBS.
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 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.
We encourage the government to engage in consultation with the medicinal cannabis industry to develop legislation and policy that will better support patients and facilitate access.