The Australian Medical Association says robust regulation of the medicinal cannabis industry is needed to tackle a ‘highly concerning and rapid increase’ in medicinal cannabis prescribing.
In a submission to the Therapeutic Goods Administration (TGA) the AMA noted its members had been appalled by the behaviour of some medicinal cannabis entities, most notably in the dispensing of medicinal cannabis.
AMA President Dr Danielle McMullen said the AMA supported proposed changes that would make it easier for regulators to address the industry’s exploitation of the Special Access Scheme (SAS) and Authorised Prescriber Scheme (APS).
‘The TGA has provided examples of a medical practitioner treating more than 31,000 patients with medicinal cannabis within six months and a nurse practitioner submitting applications for medicinal cannabis despite being subject to prescribing restrictions,’ said Dr McMullen.
‘These schemes are very necessary and allow doctors to provide access to certain specialised unapproved therapeutic goods to patients who are very ill, but they have been exploited by the medicinal cannabis industry.
‘The TGA has no role in regulating health professional behaviour and this must not change,’ she said.
‘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.’
Frustration
Dr McMullen said one of the AMA’s greatest frustrations was the amount of time and effort the TGA and stakeholders like the AMA spend trying to ensure a minimum safety and quality framework for products like medicinal cannabis, because the industry refuses to engage with established regulatory processes.
‘Medicinal cannabis clinics continue to flagrantly breach the TGA’s guidelines and AMA members are increasingly reporting serious adverse outcomes for patients,’ she said.
‘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.’
