The top official overseeing medicinal cannabis in Australia has vowed to continue to ease the administrative burden on industry after conceding the current demands surrounding permit applications are “excessive”.
John Skerritt, who heads the Therapeutic Goods Administration and Office of Drug Control (ODC), said consultation is underway on a simplified process that will demand far less from applicants.
He also confirmed that a consultation period would start before the end of the year over proposals to require imported products to be GMP compliant.
Skerritt told the PharmOut Medicinal Cannabis Conference that feedback from the industry had suggested the permit process was “overly complex”, a sentiment also shared with Professor John McMillan during his review last year of the Narcotic Drugs Act.
Skerritt appeared to acknowledge that the current process – which requires an inordinate amount of time-consuming, complex and repetitive paperwork – needed reform.
“The excessive caution and high level of prescription of what was required was really a function of the fact that it was a new scheme and lawmakers were very cautious and worried about diversion of medicinal cannabis,” he said.
“Now it’s proposed to simplify the information required in an application for a permit authorising cultivation. Extensive detail of production schemes won’t be required, so you won’t need to show [detail such as] strains, cropping schedules.”
Instead, simpler information will be required that will make it easier to understand and to comply with a permit, he said.
There will also be fewer permit variations, an area of tension in the industry. Only for a significant increase in volume, or for a change in crop cultivation from low THC to high THC will variations be required, he said.
Reform will allow companies to respond to changes in market demand without needing to consult the ODC, Skerritt added.
The consultation for the proposed reform ends in December.
Meanwhile, Skerritt said stage two of the implementation of the McMillan Review – which requires amendments to the Narcotic Drugs Act – is expected to go before Parliament before the end of the year, or early next.
The adoption of a single licensing model is chief among second stage reforms, he said.
Stage one of McMillan’s recommendations took effect on January 1 this year and included “simplified obligations”.
Skerritt also acknowledged the long-held frustrations of the industry over the funding of the ODC which many feel has contributed to long delays in obtaining licences.
But he said recent changes announced in the budget will see “funding aligned with the effort involved in regulating a scheme”.
“This means we can resource the ODC to a level that it needs to be resourced,” he said. “We are aware of the challenges it has created for the industry where we’ve had an under-resourced ODC in a fees and charges system, but now we will be able to resource to the necessary level.”
Staffing will rise from the 20-strong workforce to 32 by the 2023/24, he added.
Earlier, Skerritt acknowledged the inequitable legislation that requires local product to meet GMP quality standards, while imported product does not.
He told the conference that under current law, the Department of Health is unable to to enforce GMP standards on product that is manufactured overseas and shipped to Australia.
“Because of this uneven playing field the government is currently considering whether amendments to TGO-93 should be applied so that imported cannabis is manufactured in accordance with GMP requirements,” he said.
“Consultation is anticipated to commence later this year, and in early 2021 we’ll go to the government with options.
“I can’t pre-empt what their decision will be but at least I can commit to consultation.”
Meanwhile, Skerritt said the government is in the process of finalising its response to the Senate Inquiry held earlier this year.