In a guest editorial, the team at Cannabiz asked medicinal cannabis providers what they thought of the TGA’s plans to boost regulatory action. Here’s what they had to say.
For years now – ever since campaigners celebrated legalisation in 2016 – elements of the established healthcare sector have largely questioned the merits of medicinal cannabis.
Over the past 12 months, that has grown into open hostility.
Letters have been fired off to regulators and to federal and state health ministers warning of the perils of medicinal cannabis.
Calls for regulatory action have intensified amid anecdotal reports – never backed up with data – of the harm it was apparently causing, while conveniently ignoring the obvious benefits so many people clearly receive.
Fuelled by unfavourable coverage in the mainstream media which amplified examples of unscrupulous prescribing and unethical business practices, it was perhaps inevitable that something had to give.
And on Monday it did, the TGA confirming it will open a public consultation to help it determine what reform is required to the regulations governing medicinal cannabis.
Hastily convened meetings by industry groups have already taken place to discuss developments, and the topic is certain to be top of the agenda at next week’s ACannabis conference in Melbourne.
The consultation formally opens on Monday, the first day of the event, with stakeholders given eight weeks to lodge submissions.
As one executive mused: “The regulator session at ACannabis should be an interesting watch next week.”
News of the consultation has been met with mixed feelings, but with little surprise, and a realisation that reform of some form or other is inevitable.
Whether the Special Access Scheme is a fit-for-purpose vehicle for accessing medicinal cannabis is a welcome and legitimate question to address, and ridding the industry of bad actors is a clear necessity.
The critical question occupying the minds of many is just how far will the TGA go?
The medical bodies pushing for action have, at various times, called for the elimination of category 5 THC products, the removal of medicinal cannabis from the Special Access Scheme altogether, limits on THC potency and a restriction on how many times a product can be prescribed before the supplier must explain why it has not applied for inclusion on the Australian Register of Therapeutic Goods (ARTG).
All those recommendations will no doubt be aired again, this time in the formal setting of a consultation.
“It is not too alarmist to suggest this could be pivotal for the future of the medicinal cannabis industry,” one senior cannabis executive said. “But we’re fortunate to have a really balanced regulator. That said, they are under-resourced and a knee-jerk reaction is possible.
“Hopefully, common sense and logic will prevail and controls will be put in place for public safety without undermining professional clinical judgements.”
One industry commentator suggested a “best-case scenario” would be a new set of regulations that empower the TGA and AHPRA to actively collect, monitor and report on prescribing and dispensing activity.
Such a move would help the regulators identify risky patterns and intervene “before they get out of hand”.
“There may also be a requirement for new products to undergo some kind of quality compliance assessment before entering the market, to cut down on small, new fly-by-night operations.”
A worst-case case scenario could involve the TGA requiring in-depth clinical justification and assessment prior to approving any category 4/5 products, and restricting those products so they can only be prescribed via SAS-B approval “all of which would massively slow down and restrict access”.
“Another bad-case scenario would be if the regulators say you can’t prescribe medicinal cannabis via telehealth at all, or only under exceptional circumstances. That would kill off 90% of access overnight,” another observer said.
Dr David Gunn, the head of Cannabis Clinicians Australia (CCA), the sub-group of the Australian Medicinal Cannabis Association which now includes pharmacists and nurses, called for calm heads and expressed optimism that the TGA would act rationally and reasonably.
“We want to make sure patients are protected and that we don’t lose all the good that’s been done,” he told Cannabiz. “We all feel the same. We all feel so strongly about the many positive things that we’ve seen for patients, so it’s disheartening when you start to feel there’s the potential to lose the ability to prescribe cannabis, or for it to be so challenging that it’s rarely prescribed.
“Prescribers need to be taken into consideration because, outside of the extreme cases that are grabbing the media attention, there are many more conscientious physicians just trying to do a good job.
“I can’t even comprehend medical cannabis going away. That would be an incredible loss because when it’s done well, it changes lives.
“We need to assume that everyone is going to be rational and reasonable and listen to clinicians and patients. It would be such a shame to lose everything we’ve battled for over the years.”
The sentiment was echoed by Dr Orit Holtzman, vice president of the Australian and New Zealand College of Cannabinoid Practitioners.
With the regulation of individual practitioners outside the scope of the TGA, Dr Holtzman warned it might resort to a “blunt tool” that would impose unnecessary regulations on all practitioners by limiting patient access to medicinal cannabis.
“I welcome more regulation, that’s very much required, but it needs to differentiate between the good and bad actors,” she said. “Vertically integrated models of care and practitioners prescribing with no prior training or education, they are the real issues, but I worry the TGA may use a very blunt tool and restrict access.”
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Dr Holtzman said it was critical for the industry to spell out the nuances of the medicine. For example, eliminating category 5 medicine would not only restrict access to THC but deny patients therapeutically rich minor cannabinoids.
“I do feel some trepidation because I don’t want my patients to have their access restricted,” she said. “I’ve been doing this for six years now and the reason I keep doing it is because I see the results.”
Nurse practitioner Debbie Ranson described the consultation as a “critical moment for Australia” and urged the TGA not to penalise the many patients who receive benefit from medicinal cannabis.
“We absolutely support stronger product quality and safety measures, but reforms must not create unnecessary barriers for patients,” she said. “Over-regulation doesn’t improve safety. It drives patients back to the illicit market, where there’s no quality control, no clinical oversight, and far greater risks.
“The current framework through the Special Access Scheme and Authorised Prescriber pathways already provides oversight. What we need now is balanced reform. Improve education for clinicians, uphold product standards, and keep the focus on patient outcomes.
“Cannabis is medicine, and it works. Every day, I see patients who have exhausted conventional treatments finally find relief through medicinal cannabis, whether that’s reducing chronic pain, improving sleep, or coming off long-term opioids and benzodiazepines.
“We’ve seen patients reduce opioids and regain quality of life with cannabis. That progress cannot be undone.”
Concerns around limiting access will be equally pertinent for suppliers. Achieving commercial success is hard enough under the current framework, let alone in one with potentially reduced access.
Little Green Pharma chief executive Paul Long said he had mixed emotions regarding the review and the potential for regulatory reform.
“Part of me says let’s raise the bar and remove the worst offenders and move forward with this industry, but another part of me is concerned [reform] may go too far,” he said.
“Potentially limiting a THC amount – which, reading between the lines, may be a possibility – will only send patients who have come into the medical market and are engaging with a doctor back to the black market.
“We know there are some poor actors in the space, but a lot of people have done great work and helped a lot of patients so it’s naturally a worry that we might take a big step back.
“On the flip side, this could be positive in that it will support and raise the bar for everyone and this industry survives.”
Long suggested the industry must demonstrate through submissions to the TGA that it can self-regulate, something it has yet to prove it can do.
Involvement in the process from patient advocacy groups will also be key to achieving a good outcome for the industry, he said.
“There will be other medical bodies who have been sniping at the industry who will have a pretty strong voice at the table so it’s going to be challenging,” Long said. “It feels like this consultation is potentially saying that if you can’t regulate yourselves like pharma has done, we’ll come and do it for you.
“As an industry we need to get on the front foot to show we are capable of self-governing. That would deliver a far better outcome.
“We need to come together as an industry, and we should be asking patient advocacy groups to talk about how this medicine has made a big change for their network of patients. Things like that will make a big difference.”
Long welcomed discussions around the SAS-B scheme and whether it was fit for purpose, suggesting it has never felt the right place for medicinal cannabis.
“We’ve felt for a long time that it would make sense for medicinal cannabis to have its own pathway, and the TGA wouldn’t be the first regulator to do that,” he said.
Medibis managing director Angus Chapel said the focus should not be on the safety of medicinal cannabis but on rogue prescribers and certain business models. And that should fall under the remit of AHPRA, not the TGA.
“The idea that this is a safety risk is, in my view, massively overstated,” he said. “If you’re drawing a parallel between high-THC formulations and opioids, it doesn’t hold. You physically cannot overdose on high-THC cannabis. So, I don’t agree that it’s a safety issue.
“What I do agree with is that there’s probably some overprescribing going on. And I’d say follow the money. That’s where you’ll find the problem.
“As a supplier, I’ve been surprised for a long time by how far some of the closed-loop models have gone. When the motivation is profit, of course there’s a temptation to push the boundaries of prescribing and stretch the spirit of the guidelines.”
He added: “This doesn’t require more regulatory oversight – it needs an investigation into the business practices of those clinic models. That would resolve the issue.”
Given its low risk profile and therapeutic potential, policies that restrict access or drive patients to the illicit market risk doing more harm than good, according to Somai chairman and interim chief executive Michael Sassano.
“Many products in the Australian market lack robust quality controls, with questionable manufacturing and stability practices,” he said. “A consistent medicinal framework aligned with international standards would strengthen patient safety and market integrity.
“We support the TGA’s focus on oversight of unapproved products under the SAS and AP schemes. However, safety cannot be ensured without stricter manufacturing and labelling standards.
“While not part of the current consultation, vertically integrated clinic–brand models also deserve scrutiny. These structures create conflicts of interest and can compromise patient choice.
“A well-regulated, quality-first approach with the goal of increasing access is essential to protect patients and build long-term trust in Australia’s medicinal cannabis sector.”
Echoing Dr Holtzman’s view that nuances must be considered, MediCann Health chief executive Matt Shales said the potency of THC – something the consultation will address – can be misleading.
“When it comes to products with higher levels of THC, we should ensure we are looking at the full picture, such as the amount someone is being prescribed, not just the level of THC.
“In some cases, it could be more appropriate to prescribe 0.5g a day of a 30% THC flower than needing to prescribe 1g a day of a 15% THC flower to achieve the same THC dose.
“Another example could be prescribing an 80% THC vape cartridge that contains 800mg of total THC that is consumed over two to for four weeks, this is a much lower dose than someone having 1g a day of a 20% flower which would result in 800mg of THC being consumed over four days.”
Montu described the consultation as a “necessary step” towards ensuring Australia’s regulatory settings keep pace with the “rapid growth and clinical complexity of the medicinal cannabis sector”.
It revealed it has been drawing up its own set of recommendations.
“An independent panel of Australia’s leading experts in medicine and law, chaired by Professor Ian Freckelton AO KC and convened by Montu earlier this year, is currently developing a set of recommendations which we hope will help inform the shape of sensible policy reforms in the sector,” a spokesperson said.
“These policy proposals will form the basis of the group’s submission to the upcoming TGA consultation.”
The trade associations broadly welcomed the review.
Medicinal Cannabis Industry Australia said it supports the move to “gather information on whether current regulatory arrangements… remain fit for purpose”.
“The current patient access pathways were implemented nearly 10 years ago so a review is in order,” a spokesperson said. “The TGA is consulting broadly with stakeholders so the MCIA will promote this opportunity for industry to provide feedback on their knowledge, experience and observations.”
The Australian Medicinal Cannabis Association said it would comment once further information has been published about the review, although AMCA co-founder Lucy Haslam said it “remains crucial to pursue solutions that protect patients’ interests and support the broader sector, which continues to demonstrate professionalism and an abundance of ethical care”.
Meanwhile, Cannabis Council Australia chief executive Lisa Penlington called it a “timely step” in providing “clarity, consistency and a shared commitment to high standards across the health system”.
“Patients deserve therapies that meet consistent standards of safety, efficacy, and clinical oversight,” she said.
“We see this as a chance to enhance clarity, consistency and confidence – not just for patients, but for prescribers and responsible operators across the sector.
“Our submission will offer practical, evidence-led solutions to support that goal.”
The full consultation paper will be published on Monday with the TGA saying it will include “a number of questions on specific areas of interest for stakeholder input”.
“Any other relevant input is also welcome to help inform any future regulatory reform options,” a spokesperson said.
This article was first published by Cannabiz. Read the original here.