Responses to Regulator on Access

This page summarises responses to a regulator statement made in August 2017, after a national television current-affairs report on access to medicinal cannabis in Australia.

The media report

The report described patients and doctors as finding the legal pathway difficult, with some people said to be turning to illegal products. It included a legal view that the regulation was onerous and complex, while the government said approval turnaround times were often as little as two days.

The regulator statement

The Therapeutic Goods Administration said that its special access arrangements have operated for many years, with more than 20,000 approvals per year for doctors to prescribe a range of unregistered medicines. It noted that one interviewee in the report had referred to limited evidence from human trials, and suggested this helps explain why prescription levels were relatively low.

Differing views

• A legal commentator argued that individual patient applications should be judged on evidence relevant to the individual patient rather than evidence at large, and discussed a state health policy on products containing THC for younger patients.
• A pharmacy and plant-science commentator pointed to the role of single-patient (N-of-1) trials in the hierarchy of evidence, where results can be gathered over time to build a case for larger randomised trials.
• A patient-focused commentary criticised the regulator's coordination with state and territory health departments and argued for more support for general practitioners and for single-patient trials.

The responses reflect an ongoing disagreement about how much evidence is needed, and who decides. For the wider setting see Policy and The science. This is general information only, and the Therapeutic Goods Administration and the Office of Drug Control are the official sources.