Anne Urquhart (Tasmania, Australian Labor Party) Share this | Hansard source

In Australia we have a national classification system that controls how medicines and chemicals are made available to the public. Medicines and chemicals are classified into schedules in the Poisons Standard according to the risk of harm and the level of access control required to protect public health and safety. This bill, the Improving Access to Medicinal Cannabis Bill 2023, is an attempt to down-schedule substances contained in medicinal cannabis products. Furthermore, the bill attempts to remove any requirement for medicinal cannabis products to be accessed via the Special Access Scheme or Authorised Prescriber Scheme.

The Therapeutic Goods Administration are the Australian government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. The TGA have advised they have serious concerns with both proposals put forward in the bill. It seems that the impacts of the proposed bill have not been carefully considered. It leads me to question how much research and consultation went into the drafting of this bill. The government considers this proposal to be inappropriate, as the current scheduling of these substances is the result of a long and well-considered process based on clinical evidence and expert advice. I am a supporter of the well-considered use of prescribed medicinal cannabis in appropriate circumstances and have been involved in Senate committee hearings inquiring into this matter. I've met and spoken with people who use medicinal cannabis on prescription to treat medical conditions, with positive results.

In late 2019 through to the tabling of the committee's report in March 2020, I was an active participant in the Senate Standing Committee on Community Affairs inquiry into current barriers to patient access to medicinal cannabis in Australia. Subsequent to that inquiry, I worked hard in my home state of Tasmania, along with my colleague Senator Bilyk, to encourage the state government to adopt the recommendations of that inquiry and improve access to medicinal cannabis products for Tasmanians who are suffering and to bring the state into line with other states and territories.

This bill has the potential to undo much of the good work that is being done to give those who suffer from medical conditions access, where the use of medicinal cannabis products is deemed appropriate, to those products by medical prescription. The scheduling of substances contained in medicinal cannabis products is the result of a very careful and considered assessment of the most appropriate pathways to access medicinal cannabis products, based on available scientific knowledge, input from scheduling committees and expert clinical advice. I'm a great believer in science, and we should always look at the science closely.

The impacts of this bill have not been carefully considered and do not reflect expert clinical views. Cannabis, the plant, and THC, a psychoactive component of cannabis, were historically included in schedule 9, prohibited substances, of the Poisons Standard, which severely restricted patient access to medicinal cannabis for many years. A decision to amend the scheduling of CBD to a schedule 4 prescription-only medicine in March 2015 and to amend the scheduling of cannabis and THC to a schedule 8 controlled drug in August 2016 enabled prescriptions of both CBD- and THC-containing products for therapeutic purposes, subject to state and territory requirements.

But this bill proposes to down-schedule medicinal cannabis products from schedule 8 to schedule 4, which would conflict with the scheduling policy framework for psychoactive drugs that has been agreed by all states and territories through the then Australian Health Ministers' Advisory Council. The proposed down-scheduling would not in and of itself have the claimed effect of permitting access to medicinal cannabis products through any medical practitioner. This is because Authorised Prescriber Scheme and Special Access Scheme approvals are required for most medicinal cannabis products, as they are not included in the Australian Register of Therapeutic Goods.

To lawfully supply a therapeutic good that is not included in the register, one of the pathways for accessing unapproved goods, such as through the Special Access Scheme, Authorised Prescriber Scheme or Personal Importation Scheme, must be used. The rescheduling of the products would not change this in any way. So, even if this bill were to pass the chamber, it would not have the effect its proponents seem to believe it would. It's important to understand that the Special Access Scheme and authorised prescriber pathways were specifically designed to ensure both medical expertise and TGA oversight over the use of unapproved therapeutic goods for patients.

These safeguards and this level of medical oversight over the use of unapproved therapeutic goods allow safety concerns to be quickly identified while balancing the importance of ensuring patient access to new treatments. Therapeutics goods that are not on the register can be lawfully supplied only under an exemption authority or approval. This is to strike an appropriate balance between ensuring that therapeutic goods available to Australians are safe and of acceptable quality and making therapeutic goods available to Australians who need them.

The current scheduling of substances contained in medicinal cannabis products was the result of a very extensive process to ensure that the scheduling of substances is appropriate. The proposals in this bill have not undergone such extensive consideration. Another matter to consider is that, because we are a federation, the states and territories play a major role. Each state and territory has its own laws that determine where consumers can access a particular drug and how it is to be packaged and labelled. The standard is given effect through state and territory legislation, and it remains with the state and territory governments as to how they give effect to any decision to down-schedule a substance in their own jurisdiction. This bill includes a down-scheduling proposal to allow cannabis products with THC below one per cent and CBD below 10 per cent to be sold over the counter in a pharmacy or veterinarian practice to a person aged over 18. This is much greater than international practice.

Article 30 of the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 protocol, which is a treaty that Australia is a party to, requires drugs, including cannabis and extracts regardless of THC concentration, to be under medical prescription. So the proposal in this bill would not be consistent with Australian's obligations under the single convention.

Medicinal cannabis is a very fast-developing therapeutic product, not just here in Australia but across the world. There remains much to be done in this emerging area to improve access to safe, affordable and effective medicinal cannabis products, but this bill does not provide for a coherent way forward. It is not the solution to improve access to safe, affordable and effective medicinal cannabis products. It fails to take into account the processes our country uses, the nature of the Federation, the treaties we are signatories to as well as the safety mechanisms we have in place when it comes to the prescription of medicinal cannabis products that are unapproved by the TGA.

It is possible that this bill is the result of frustration as to what some may see as the slowness of the processes that allow the approval of products and their scheduling on the Australian Register of Therapeutic Goods. Therapeutic goods are assessed according to their level of risk against acceptable standards of quality, safety and efficacy or performance. The scheduling of substances contained in medicinal cannabis products is the result of a carefully and considered assessment of the most appropriate pathways to access medicinal cannabis products based on available scientific knowledge and input from scheduling committees and expert clinical advice. Those processes and assessments are there to ensure medicinal cannabis products are safe, effective and meet specific manufacturing and product quality requirements. These processes and assessments take time.

Progress is being made however. At this time two medicinal cannabis products have been evaluated and approved by the TGA and are included on the Australian Register of Therapeutic Goods—Sativex, which is used to treat certain patients with multiple sclerosis, and Epidiolex, which is used for patients with certain epileptic conditions. I have heard firsthand of the great benefits that these have brought to some sufferers of epilepsy and certain multiple sclerosis, and I'm excited by the science and the discoveries that are being made.

As our medical practitioners are increasingly finding, access to medicinal cannabis products in Australia is straightforward and almost 300,000 prescriptions for medicinal cannabis have been written in recent years. Most of these medicinal cannabis products are unapproved therapeutic goods. Through the special access scheme the TGA can approve any medical practitioner to supply an unapproved medicinal cannabis product for an individual patient, typically within just a few days. In addition, under the Authorised Prescriber Scheme, a suitably authorised doctor can prescribe products without obtaining patient-by-patient approvals from the TGA, and, as the evidence base is increasing, more prescribers are accessing unapproved medicinal cannabis products for their patients through these access pathways.

As we learn more and as the science and research is done, more products will become available both as unapproved medicinal products and as medicines on the Australian Register of Therapeutic Goods. I have no doubt there is a lot yet to learn about the possibilities and benefits of these products, but this bill will do nothing to advance them, make them safer or more available.