Australian Medical Association supports a crackdown against the abuse of Special Access Schemes (SAS) in Australia and Authorised Prescriber Schemes (APS); particularly with regard to medicinal cannabis.
SAS and APS provide regulatory paths that enable patients to obtain unapproved medical products.
SAS enables patients on an individual basis to have access to these products. A healthcare professional will need to apply on behalf of the affected patient to Therapeutic Goods Administration. The APS allows approved doctors to prescribe unapproved drugs to a group of patients who have a specific medical condition without having to submit an application for every case.
In 2016, medical cannabis became legal in Australia. While MC prescribing is tightly controlled in the country, there are weaknesses in regulations – particularly given the rise of telehealth. A medical doctor who treated more than 31,000 patients in six months with MC is an example of this.
The AMA is in favor of sharing relevant information about cases such as this with the Australian Health Practitioner Regulation Agency for further investigations.
The TGA does not have a role to play in the regulation of health professionals’ behaviour, and that must remain unchanged. said AMA President Dr Danielle McMullen . The AMA President Dr Danielle McMullen.
The AMA submitted a submission to TGA that included additional suggestions.
“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. It is not reasonable for medical cannabis products to have a THC percentage so high, and yet it is one of the most prescribed categories.
Also, the AMA expressed its preference for therapeutic products to be registered in the Australian Register of Therapeutic Goods.
The TGA must consider reforms to limit the number of products that can be accessed via a SAS, before the company is required to register with the ARTG.
Submission of the AMA to TGA in full can be viewed here.