What might be about to change in Aussie pot (hint: it’s not recreational)
Health & Biotech
Health & Biotech
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Mutterings within Australia’s legal marijuana industry have grown over the last 12 months against the red tape perceived to be at the heart of why the local industry is growing so much more slowly than in other countries, such as Germany.
Industry, health and policy people voiced these mutterings to a statutory review between February and April, with the main demand being for change to the complex licensing system.
Twenty organisations and people proposed a shopping list of changes for the report, due on October 29, to include or discard.
Almost all of the 17 public submissions identified burdensome regulation as the key issue they want changed.
“Anecdotal evidence, along with data available, is indicating a sector that is overwhelmed at every level,” said LeafCann, a company looking to list over the next 18 months.
“While there has been improvement over the last 12 months this is still a major concern for those in the sector, that there is still some way to go before Australia has an efficient and effective regulatory system in place.”
The review, led by Australian National University Professor John McMillan AO, looked at the efficiency around the licensing and permitting regimes, the general red tape burden, and whether the compliance and enforcement processes were appropriate.
It did not consider patient access or whether the Pharmaceutical Benefits Scheme (PBS) should subsidise medical cannabis, recreational use, State and Territory regimes, or drug registration.
The carve-outs were scorned by United in Compassion (UIC), a patient access organisation whose data was cited by several other submitters.
“This we believe to be nonsensical – and an attempt by officials to limit the damage and embarrassment such a Review Process may cause by casting light upon what has been, from the outset, disastrous legislation and execrable public policy causing untold damage to sick Australians,” the UIC submission opened with.
Of course, a number of submissions pressed for the review to incorporate one or more of these.
It also outlined what applicants are paying for the privilege of working with medical marijuana: $27,380 a year for a licence, $5040 per licence application, and $1830 for a permit application, the certification that allows commercial or research activities to actually start.
The key issue for the corporations offering opinions to the review was the licensing system, a process that can take up to two years from application to receiving certifications that will allow them to grow or manufacture product.
Currently companies must apply for a cultivation licence to grow, an R&D licence to undertake research, and a manufacturing licence if they want to make products. In order to start commercial operations they also need a permit.
Industry bodies want existing licence holders to get priority for new applications and licence changes.
Tasmanian Alkaloids summed up the key friction points:
Sydney University’s Lambert Institute added there should be minimum turnaround times for applications, each one should have a case manager to avoid applicants having to deal with multiple people, and there should be an online portal through which applicants can share information with the Office of Drug Control (ODC).
Industry lobby group Medical Cannabis Industry of Australia (MCIA), which consists of Althea (ASX:AGH), Cann Group (ASX:CAN), AusCann (ASX:AC8), Cronos Australia, MedCann, Med Releaf, THC Global (ASX:THC) and LeafCann, said its members had problems with the ODC’s lack of transparency; the inability to track the progress of a submission and online portal; and the lack of timelines as the TGA has.
“The Narcotics Drugs Act [the legislation that manages the medical cannabis industry] is also being operationalised in isolation,” MCIA said.
“There is no recognition that the industry operates in a well-established regulatory framework which is proficient in dealing with controlled good phyto pharmaceuticals (e.g. poppies and thebaine).”