The Australian Medical Association (AMA) is supporting a crackdown on exploitation of the country’s Special Access Scheme (SAS) and Authorised Prescriber Scheme (APS); particularly in relation to medicinal cannabis (MC).

The SAS and APS are regulatory pathways that allow patients to access unapproved therapeutic goods when necessary.

The SAS enables individual patients access to such products on a case-by-case basis, but a healthcare practitioner must apply to the Therapeutic Goods Administration (TGA) on the patient’s behalf. The APS enables approved medical practitioners to prescribe specific unapproved products to a class of patients with a particular medical condition, without needing to apply for each individual case.

Medical cannabis was legalised in Australia in 2016. While MC prescribing is tightly controlled in the country, there are weaknesses in regulations – particularly given the rise of telehealth. An example of a concerning situation was a medical practitioner treating more than 31,000 patients with MC within six months.

The AMA supports relevant information for cases like this being shared with the Australian Health Practitioner Regulation Agency (Ahpra) for further investigation.

“The TGA has no role in regulating health professional behaviour and this must not change,” said AMA President Dr Danielle McMullen . “But it’s reasonable to expect that a practitioner applying to provide patients with access to unapproved therapeutic goods would be subject to appropriate scrutiny, and that the TGA can share that information with the appropriate regulator when there is genuine concern about their behaviour.”

In its submission to the TGA, the AMA has suggested additional changes.

“We have also recommended the TGA considers reforms to how unapproved medicinal cannabis products are accessed beginning with a review of the categories of medicinal cannabis products, and the complete removal of category 5 — products with a THC content greater than 98 per cent — while the review is conducted,” said Dr. McMullen. “There is no reasonable justification for medicinal cannabis products to contain such a high percentage of THC, yet we understand it is the most frequently prescribed of the categories.”

Furthermore, the AMA has expressed its preference that therapeutic products be registered on the Australian Register of Therapeutic Goods (ARTG).

“To ensure the SAS is not used as a loophole to avoid registering on the ARTG, the TGA should consider reforms that would limit the quantity of products accessed through a SAS before it has to register on the ARTG or lose access through the SAS or APS.”

The AMA’s full submission to the TGA can be viewed here.