Dr Teresa Nicoletti, Partner, and Darcy O’Brien, Lawyer

On 29 January 2020, Australian senators, advocacy groups, stakeholders and industry experts gathered in Melbourne to attend the public hearing of the Senate inquiry into current barriers to patient access to medicinal cannabis in Australia (the Inquiry).

Mills Oakley prepared a comprehensive written submission to the Inquiry, authored by Dr Teresa Nicoletti, who also appeared at the Inquiry as an expert witness.

The Inquiry

The Senate referred the Inquiry to the Senate Community Affairs References Committee on 14 November 2019. The scope of the Inquiry was broad, with its terms of reference covering most aspects of the chain of supply of medicinal cannabis in Australia, such as:

• the appropriateness of the current regulatory regime;
• interaction between state and territory authorities and the Commonwealth;
• training, education and sources of information for doctors as to the prescription and use of medicinal cannabis; and
• barriers to accessing medicinal cannabis legally, such as availability in rural areas and financial barriers.

Submissions

Written submissions for the Inquiry were received from a broad range of stakeholders, including:

• patients and their families, who have both been impacted by the current barriers to accessing medicinal cannabis;
• industry groups;
• public departments, including the Department of Health; and
• industry experts.

The written submissions were then assisted by oral testimony given by witnesses at a public hearing on 29 January 2020. At the hearing, the following issues emerged as significant barriers to patient access:

• State and territory restrictions: State and territory regulatory frameworks were criticised for obstructing patient access to medicinal cannabis, which has delayed patient access which has been approved at the Commonwealth level. Reasons for this obstruction were cited as duplicative hurdles, intervention from state and territory authorities, and interference by state and territory policy. A uniform framework which excludes state and territory intervention in access decisions was a key recommendation from stakeholders.
• Availability of doctors who are willing to prescribe medicinal cannabis: A spotlight was placed on the limited education and resources available to doctors regarding the therapeutic uses of medicinal cannabis, resulting in a collective lack of knowledge and understanding of cannabis-based medicines amongst the majority of medical practitioners in Australia. This was said to create the first hurdle to patient access, being many patients’ inabilities to find a doctor who will actually consider prescribing medicinal cannabis.
• Cost: The expensive cost of medicinal cannabis was viewed as a major impediment to patient access, with two main factors identified as contributing to this high cost; the lack of government subsidies and the absence of a domestic industry. Witnesses reported treatment costs of up to $100,000 per year depending on the medical condition, which would be well beyond the reach of almost all patients. The Pharmaceutical Benefits Scheme was also identified as being currently unsuitable for subsidising patient access to cannabis medicines.
• Driving laws: driving laws in NSW create a strict liability offence if tetrahydrocannabinol (THC) is detected in any person driving a vehicle, regardless of whether that person has a legitimate reason. There are similar offences in other states and territories. This legislation was cited at the public hearing as a further major deterrent for patients who wish to access medicinal cannabis, but rely on driving for employment reasons. Patients have reported obtaining a lawful prescription for medicinal cannabis, but then not filling the prescription for fear of THC being detected in their system while driving.

Outcomes

At the very least, the Inquiry has put the spotlight on the many issues that need to be addressed in order to facilitate better patient access to medicinal cannabis across Australia, with the Committee acknowledging the numerous barriers that are currently stifling access.

The Department of Health (DoH) appeared at the public hearing and was engaged in a very informative and robust discussion with the Committee – the transcript of that discussion is available here.

Most interesting to come out of that is the discussion about the possible down-scheduling of low-dose cannabidiol to an over-the-counter medicine.[1] The Department says it is doing a “study”, “of [its] own volition” about the feasibility of down-scheduling, which it says will be submitted to the Scheduling Committee for advice and, very likely, will trigger a public consultation process.

That is certainly a welcome development and step in the right direction, but it does not address the several other key issues, laboured before the Committee, which are stifling access.

What’s next?

The Senate is due to report on its findings by 26 February 2020. We will issue a further update after the report is issued, which we anticipate will make some strong recommendations that will ultimately be positive for patients and other stakeholders in the Australian medicinal cannabis industry.

If you are interested in reading Mills Oakley’s submission to the Inquiry, it is available online here. The transcript of Dr Nicoletti’s appearance before the Committee is available here.

For further information or if you require advice about patient access issues, contact Dr Teresa Nicoletti at [email protected] or on 02 8035 7860.

[1] What constitutes low-dose cannabidiol has not yet been defined.