Mills Oakley partner Dr Teresa Nicoletti and lawyers Ella Adams and Rebecca Pecovski examine what One Nation's proposed medicinal cannabis access bill would mean for patients should it pass into law.
One Nation leader Pauline Hanson recently tabled the Improving Access to Medicinal Cannabis Bill 2023 in the Senate. The explanatory memorandum that accompanies the bill outlines its core proposals:
- rescheduling medicinal cannabis to schedule 4, which would permit any registered medical practitioner to prescribe it;
- adopting a definition of cannabis that permits a higher THC threshold, raised from 0.1% to 1%, which its authors contend falls below the level recognised as producing any hallucinogenic effect and would align Commonwealth law with state and territory legislation;
- permitting the over-the-counter sale of whole-plant cannabis products — with a ceiling of 1% THC and 10% CBD — at pharmacies or through veterinarians to individuals aged 18 and over; and
- retaining the current hemp food product listing with existing limits left intact.
According to the memorandum, these changes would purportedly:
- eliminate the need for the Approved Prescriber Scheme (APS) and Special Access Scheme (SAS) as pathways to medicinal cannabis; and
- open the door for medicinal cannabis products to be listed on the Pharmaceutical Benefits Scheme (PBS).
The bill's stated goal is to broaden access for Australians and their animals alike. The question is whether it actually accomplishes that.
The Poisons Standard
Poisons and medicines are assigned to different schedules under the Poisons Standard, with each schedule reflecting a substance's intended use and potential for harm.
Each schedule carries its own set of controls governing labelling, sale, purchase, storage and disposal. Controls become less stringent as the schedule number decreases.
The majority of cannabis products fall under schedule 8, while those containing predominantly CBD are listed under schedule 4.
Scheduling decisions turn on a risk-benefit assessment that takes into account factors including:
- the toxicity of the substance;
- its intended use, including the diagnostic decision involved;
- potential for abuse and misuse;
- safety considerations, including whether specialist training or protective equipment is required; and
- the benefits associated with access to the substance.
Nothing in the bill's drafting suggests these factors were weighed, and the bill proposes to amend the Poisons Standard by moving currently schedule 8 medicinal cannabis products down to schedule 4.
While such a change would reduce the regulatory requirements around labelling, storage, sale, supply and disposal, the rescheduling would have no effect on the obligation for prescribers to secure approval or authorisation under the SAS and APS before supplying medicinal cannabis products, nor on the prospect of PBS reimbursement.
The reason is straightforward: most medicinal cannabis products are not registered in the Australian Register of Therapeutic Goods (ARTG).
Accessing unapproved medicinal cannabis products
Therapeutic goods earn their place in the ARTG only after the Therapeutic Goods Administration (TGA) has assessed and confirmed that their quality, safety and efficacy meet the required standard.
The registration pathway is a demanding one, requiring applicants to submit a comprehensive dossier of clinical, preclinical, chemistry and manufacturing data to the TGA.
The cost of preparing such a dossier is significant, and the challenge is compounded in the case of medicinal cannabis by the comparatively thin body of scientific evidence supporting its efficacy across most indications.
Consequently, only two medicinal cannabis products — Sativex and Epidyolex — are currently registered in the ARTG.
Whether a product is classified as schedule 4 or schedule 8, medical practitioners cannot lawfully prescribe unapproved medicinal cannabis products outside the SAS or APS frameworks, or outside an ethics committee-approved clinical trial.
It is therefore difficult to see how the bill, as currently drafted, could possibly remove the need for the SAS and APS.
Issues hampering access to medicinal cannabis
We do not agree that the current scheduling framework, combined with the SAS and APS, is what is preventing Australians from accessing medicinal cannabis.
Schedule 8 medicines carry additional controls compared with schedule 4 medicines, but in general terms, any patient seeking medicinal cannabis for a genuine therapeutic purpose can obtain it.
The additional controls may contribute to the administrative burden that affects supply costs, but a medicine's scheduling does not materially determine whether patients can access it.
On the question of access, the TGA reported that between July 2016 and July 2022, 1,157,195 patients accessed medicinal cannabis through the APS, and 344,695 SAS-B applications received approval.
The genuine barriers to medicinal cannabis access relate to cost, which can be prohibitive, and to the state and territory drug-driving laws that effectively deter patients with legitimate medical need from pursuing treatment out of fear of prosecution under what we regard as outdated laws that should have been reformed when medicinal cannabis was legalised in 2016.
While more affordable medicinal cannabis products would undoubtedly improve accessibility, we do not accept that the proposed amendments to the Poisons Standard would facilitate PBS listing.
A PBS listing application requires the preparation of detailed submissions reviewed by the Pharmaceutical Benefits Advisory Committee (PBAC), which makes recommendations to the Minister for Health and Aged Care on which medicines should receive a subsidy.
In formulating those recommendations, the PBAC must assess the effectiveness and cost of therapy, typically by comparing the medicine against alternative therapies already listed on the PBS.
Given the limited scientific evidence available for medicinal cannabis across most indications, any company seeking a PBS listing would be unlikely to possess the data needed to demonstrate comparative effectiveness and cost.
Rescheduling medicinal cannabis products from schedule 8 to schedule 4 does nothing to address that problem — the scheduling of a medicine has no bearing whatsoever on its eligibility for PBS listing.
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.
