Restricting access to medicinal cannabis would simply push patients to the black market, further undermining their health, the Penington Institute has said, as it became the latest body to question the reported harms the medicine is said to be causing.
Despite repeated concerns raised by medical bodies, the drug policy think tank said there remains a “lack of clear evidence” linking medicinal cannabis to public health harms.
What data there is, including an Australian Institute of Health and Welfare paper showing a spike in cannabis-related hospitalisations in 2019-20, does not distinguish between prescribed and illicit cannabis use, it said.
“This is the sole data point provided in the [TGA’s] consultation paper to illustrate population-level harms,” Penington wrote in its submission to the review.
It said that if medicinal cannabis has led to patient harm, as suggested by the Australian Medical Association and others, “we would expect to see indicative evidence of an increase in such harms over this period”.
“There is very little publicly available, systematic data that offer clear understanding of medicinal cannabis’s role in the prevalence, nature, and trajectory of cannabinoid-related harms,” the think tank said. “And visible data does not reveal any evident causal connection between medicinal cannabis access and reported harms.”
However, it did not discount the possibility. Just as the experience of patients who report therapeutic benefits of medicinal cannabis should be respected, so should the observations of healthcare professionals who have anecdotally reported increases in harm, the submission said.
Penington warned that should the TGA introduce reforms that limit access to medicinal cannabis, far from safeguarding public health, it will expose patients to “unnecessary risk” by driving them to the black market.
It called on the TGA to conduct a formal analysis of the risks associated with such a scenario.
“Continuity of care for hundreds of thousands of patients would be interrupted and many patients would doubtless return to – or seek out for the first time – Australia’s affordable and easily accessible criminal cannabis market,” it said.
“In addition to a complete lack of quality assurance and exposure to drugs far riskier than cannabis, illicit market suppliers have a history of targeting sick and vulnerable Australians…when access to legal, regulated products is restricted.”
While stressing the need for medical pathways to remain open and accessible, it acknowledged the “quality, safety and regulatory oversight” of medicinal cannabis must be improved.
“Continuity of care for hundreds of thousands of patients would be interrupted and many would doubtless return to – or seek out for the first time – Australia’s affordable and easily accessible criminal cannabis market”
penington institute submission to tga consultation
That can be achieved through a fee-based registration process where every product is assessed by the TGA for quality and safety standards prior to market entry. Demonstration of efficacy would not be required, however.
Meanwhile, pharmacovigilance responsibilities would switch from prescribers to sponsors.
Penington predicted the system would see sponsors seek approval for only a “small number” of products currently available, “enhancing capacity for regulatory oversight”.
Other recommendations tabled by Penington include improvements to data collection and analysis that better sets out the therapeutic benefits and risks associated with medicinal cannabis.
The development of a purpose-built framework to replace the current product categorisation system was also suggested.
Penington said a new structure would take into account both THC content and route of administration with the potential to introduce notification-only requirements for lower-risk products “while retaining or fortifying safeguards and oversight for higher-risk prescribing”.
Acting chief executive and director of research Jake Dizard said the TGA consultation offers a “crucial opportunity to improve confidence in the medicinal cannabis regime”.
“A pragmatic, evidence-based approach is required. The TGA must make sensible improvements without creating new barriers to patient access,” he said.
“The last thing we want is for medicinal cannabis to be so difficult to access that people simply switch to easily available illicit cannabis.
“Ultimately, Australia needs a wholesale realignment of cannabis policy, including the introduction of regulated adult access to cannabis for non-medicinal use.
“Broad and common-sense cannabis regulation will take pressure off the medicinal cannabis sector and help reduce harms across the broader community.”