Queensland State Parliament late last night unanimously passed the Public Health (Medicinal Cannabis) Bill 2016 (Qld) (Bill). The Bill, when introduced earlier this year, was heralded as a “milestone” in Queensland law on access to medicinal cannabis products.

Earlier this year we examined the Access to Medicinal Cannabis Act 2016 (Vic) (AMCA), passed in Victoria in April. As we noted then, new state laws relating to medicinal cannabis should be critically assessed in the context of Commonwealth law and the existing regulatory framework administered by the Therapeutic Goods Administration (TGA).

Unlike the AMCA, the Queensland Bill is not intended to regulate the manufacture of medicinal cannabis products, only their supply to patients in Queensland. However, we are concerned that the Bill, like the AMCA, imposes an additional regulatory scheme which applies only to medicinal cannabis products, and duplicates or encroaches on the existing regulatory role of the TGA.

Framework under the Bill

The Bill establishes two approval pathways for treatment with medicinal cannabis for patients in Queensland. Notably, this regime applies only to medicinal cannabis products which have not been listed or registered on the Australian Register of Therapeutic Goods (ARTG). Approvals authorise medical practitioners, patients and pharmacists to possess and deal with certain medicinal cannabis products.

Patient-class prescribers

Under the Bill, regulations may be made to stipulate classes of specialist medical practitioners who will have an as-of-right authority to prescribe medicinal cannabis products, subject to conditions. Regulations may also limit approvals to certain classes of patient and types of treatment.

When the Bill was introduced, Health Minister Cameron Dick indicated that doctors specialising in paediatric neurology, oncology and palliative care would be the first to be given patient-class prescriber status.

Notably, patient-class prescriber status does not affect the operation of the Commonwealth Therapeutic Goods Act 1989, under which products not listed or registered in the ARTG may only be supplied where certain exemptions apply.

In practice, in order to take proper advantage of patient-class prescriber status under the Bill, medical practitioners will also need to be approved under the TGA authorised prescriber scheme. Approval as an authorised prescriber involves an assessment by the TGA of the practitioner, treatment and proposed class of patients. In effect, the patient-class prescriber scheme under the Bill operates only to restrict the operation of the Commonwealth authorised prescriber scheme.

Further, it appears that patient-class prescribers will be subject to an additional administrative burden, being required to report each prescription to the chief executive of Queensland Health, in addition to the TGA (as is required under the authorised prescriber scheme).

Single-patient approvals

Under the Bill, if a medical practitioner, patient, condition, or medicinal cannabis product falls outside the scope of any existing patient-class approval, the medical practitioner must seek a single-patient medicinal cannabis approval in order to prescribe medicinal cannabis. Medicinal cannabis approvals prescribe the form, dosage and dispensing intervals of the product, as well as specifying the particular pharmacy from which the product will be dispensed.

Applications for single patient approvals are assessed by the chief executive of Queensland Health, who may consider:

  • whether the applicant is a suitable person to hold the approval;
  • whether the patient is a suitable person to undergo the treatment;
  • the patient’s medical condition and associated symptoms;
  • the form and dosage of the treatment;
  • whether the treatment can be integrated into the patient’s existing treatment;
  • alternative treatments available;
  • the patient’s history of drug dependence, if any, including use of cannabis; and
  • any other information or matters contained in the application, or which the chief executive reasonably considers relevant.

The chief executive may also require the applicant to provide additional information, seek a written opinion from a relevant specialist (whether or not the applicant is themselves a specialist in the area), or refer the application to an expert advisory panel.

Notably, on top of the above considerations, under section 24, the chief executive may only grant an approval if:

  1. the applicant is a suitable person to hold the approval;
  2. the patient is a suitable person to undergo treatment with medicinal cannabis;
  3. the medicinal cannabis to which the approval will apply
    1. has, or will be, manufactured or imported in accordance with the applicable law of the Commonwealth; and
    2. is, or will be, able to be supplied, for the purpose of treating the patient, in accordance with the applicable law of the Commonwealth.

The effect of the final provision is that the chief executive may not grant a medicinal cannabis approval unless access to the product is (or will be) approved by the TGA – for example, through the special access or authorised prescriber schemes. Notably, these schemes already involve application and approval processes administered by the TGA, which traverse most or all of the matters to be considered by the chief executive under the Bill.

We are therefore concerned that the chief executive approval scheme in the Bill amounts to double-regulation of medicinal cannabis treatments in Queensland which must necessarily have already passed substantially similar hurdles at a Commonwealth level. This is particularly concerning when medicinal cannabis approvals under the Bill can take up to 90 days, or longer if the application is “complex” or the chief executive requests further information.

Dispensing approvals

The Bill also establishes an approval scheme for dispensing pharmacies. On an application for a dispensing approval, the chief executive may consider the following:

  • whether the applicant is a suitable person to hold the approval;
  • the applicant’s familiarity with the use of medicinal cannabis;
  • the location and facilities of the pharmacy; and
  • any other information or matters contained in the application, or which the chief executive reasonably considers relevant.

Again, this is an additional set of requirements imposed only with respect to medicinal cannabis products, and no other drugs. We note that Chapter 2 of the HDPR already imposes rigorous standards on pharmacies dispensing Schedule 8 substances.

Approvals generally

The Bill empowers the chief executive to request criminal history checks of applicants (medical practitioners and pharmacists) as well as patients, and obliges the police commissioner to notify the chief executive of any future offences charged.

The Bill also sets up a number of new criminal offences associated with medicinal cannabis, including:

  • possessing, obtaining, manufacturing, supplying, administering, or destroying medicinal cannabis without holding an approval;
  • obtaining or attempting to obtain medicinal cannabis based on a false prescription;
  • making a false or misleading statement in an application for an approval; and
  • failing to comply with conditions on an approval, a compliance notice, or a recall order.

In our view most if not all of these activities would already constitute offences under the DMA or otherwise.


There appears to be a particular stigma attached to the prescription and supply of medicinal cannabis products which is evidenced in the Queensland Government’s regulatory approach.

The Bill sets up a new system of approvals that applies only to medicinal cannabis products. The scheme involves character tests, criminal history checks, and delays of up to 90 days, in relation to treatments which must already have been assessed at a Commonwealth level. No other scheduled substances (some of which have highly significant risk profiles and potential for abuse) are subject to these requirements.

In allowing access to medicinal cannabis products for Queenslanders, the Bill is welcome. However, in our view, as passed, the Bill creates unjustified obstacles which may needlessly delay or prevent patients’ access to these products.