The medicines regulator has officially opened consultation on new cannabis rules.
The Therapeutic Goods Administration has laid out its case for medicinal cannabis reform in a consultation paper, as groups like medicinal cannabis telehealth giant Montu claim to welcome regulation.
Announced last week and opened on Monday, the TGA consultation is exploring three key issues; the appropriateness of the unapproved goods pathway for medicinal cannabis access, safety and quality concerns and the impact of direct-to-consumer telehealth models.
There are two pathways by which patients in Australia can access an unapproved product legally: the Approved Provider (AP) pathway and the Special Access Scheme (SAS).
Initially, the TGA said, it had anticipated that allowing access via the AP and SAS scheme would support products to be registered on the Australian Register of Therapeutic Goods (ARTG).
It had also expected that a relatively small number of prescribers would be prescribing medicinal cannabis, that only patients with very specific clinical needs would be receiving those prescriptions and that there would only be a small number of products supplied as a result of those prescriptions.
Not everything went according to plan.
“The unapproved pathways used by prescribers to access medicinal cannabis products, traditionally used as exceptional access mechanisms for unapproved goods, are no longer appropriate due to the high volume of patients accessing an ever-increasing range of products,” the consultation paper read.
“These products have not undergone any regulatory review or evaluation of their quality, safety, efficacy or performance.
“Further, the ready access provided via these pathways has reduced or removed the incentive to collect the robust safety, efficacy and performance data necessary for the evaluation and registration of a medicinal cannabis product on the ARTG.”
One of the quirks of the TGA system is that, when a product is listed on the ARTG, the sponsor has to provide the regulator with detailed information about the safety, quality and efficacy of that medicine.
This includes details like the manufacturing process, the dosage form, the route of administration and information relating to the product’s proposed indications.
The sponsor is also obligated to monitor the use of its products and report back to the TGA on adverse events or side effects.
Related
Sponsors of unapproved therapeutic goods do not bear this burden – they are not even automatically required to provide samples at the TGA’s request.
In the 10 years since regulations were relaxed, only two medicinal cannabis products have been added to the Australian Register of Therapeutic Goods; more than 99% of the medicinal cannabis products being prescribed in Australia are unapproved.
Prescriptions have also been on the rise. Earlier this year, AHPRA released data indicating that there were around 2100 prescribers using the SAS and around 1100 prescribers using the AP pathway.
Some practitioners have allegedly written more than 10,000 medicinal cannabis scripts within a six-month timeframe.
Essentially, the TGA is now in a position where an increasing number of patients are accessing products that it has no insight into the safety of – and, because access pathways are relatively simple and patient demand is high, the makers of those products are not incentivised to submit to the TGA’s rulebook.
“The TGA is not intending to remove access to medicinal cannabis products,” it said.
“Rather, we aim to ensure that products being supplied are of appropriate quality, there is confidence in the level of safety, efficacy and performance, and further evidence is being generated to support legitimate use as a therapeutic good.
“If safety signals with certain unapproved medicinal cannabis products are identified through this consultation, the TGA will take prompt and appropriate regulatory actions to provide greater assurance of the safety of medicinal cannabis products.”
Montu, a group which owns multiple vertically integrated cannabis companies and operates one of the more prominent medicinal cannabis-focussed telehealth clinics, has publicly welcomed the opening of the consultation.
It is also the subject of proceedings in the Federal Court of Australia brought by the TGA for alleged unlawful advertising of medicinal cannabis on websites and social media.
Both sides have reportedly entered mediation.
“Ten years after a temporary legislative framework was established, Australia’s medicinal cannabis system is overdue for reform to ensure it more effectively supports clinical practice,” Montu said.
“Thousands of Australians are prescribed medicinal cannabis to manage their chronic conditions and they deserve a system that puts safety, clarity and access first.
“Sensible reform would give clinicians the confidence and consistency they need to deliver appropriate care, particularly when it comes to navigating inconsistent labelling and widespread confusion about tetrahydrocannabinol (THC) strength.”
Pharmaceutical Society of Australia president Associate Professor Fei Sim, meanwhile, said the SAS and AP schemes were designed for unique clinical situations, not a loophole to bypass regulatory scrutiny.
She also called for more action from other regulators in the space.
“More needs to be done to curtail aggressive telehealth services that, in many cases, appear to lack robust clinical governance,” Professor Sim said.
“There is a place for medicinal cannabis products, but we need to prioritise the tools and regulatory environment that promote their safe and appropriate use.”
