![Wendy Bonython](https://bond.edu.au/sites/default/files/styles/wide_l/public/2024-08/ARC-LAW-CAV_7843.jpg?h=75ca4024&itok=8GAJq0fz)
by Dr Wendy Bonython
YOU CAN LISTEN TO THIS STORY HERE.
For more than 40 years, Amsterdam has been a favourite destination for young Australians drawn to its historic charm and famously relaxed cannabis scene.
While the Dutch capital is now stepping back from its freewheeling drug culture, citing concerns over crime and public disorder, Australia is set to shift from sending cannabis tourists to Europe to becoming a key supplier of the drug itself.
Producing and selling medicinal cannabis took off in 2016 when strict regulations permitted Australians to access and produce these products legally.
The history of cannabis as a prohibited drug means its production is heavily regulated However, there is a growing movement towards legalisation and decriminalisation which reflect changing attitudes towards its use for both medical and recreational purposes.
Global legal cannabis spending reached more than $56 billion in 2022 and is set to reach $153 billion by 2027 according to market analyst Euromonitor International, with the European economic value projected to grow from $821 million to $3.3 billion by 2027.
Australian farmers are already positioning themselves to capitalise on this growth by signing multimillion-dollar export deals.
Some in the industry are confident France will fully legalise its medicinal market in 2025, offering further opportunities for Australian exporters.
Commercial production of medicinal cannabis attracts significant ethical, regulatory, and legal safeguards intended to prevent it from ending up with recreational users.
But if Australian farmers can navigate these issues, they stand to gain significantly from the lucrative global market.
Acceptance of medicinal cannabis as lawful and socially accepted is growing as the health benefits become more widely known and proven.
These include:
• Reduction of nausea, vomiting, pain, and muscle spasms.
• Improvements in sleep and appetite.
• Management of seizures.
• Relief of chronic pain.
• Treatment of neuropathic pain.
• Nausea and vomiting associated with cancer chemotherapy.
• Improving appetite in people with cancer and HIV/AIDS.
• Treatment of multiple sclerosis.
However, the medicinal pathway is still hampered by the fact recreational cannabis use remains controversial and criminalised in many countries, including Australia.
A 2024 Senate Committee enquiry into the Greens’ Legalising Cannabis Bill 2023, which included proposals to legalise and commercialise recreational cannabis, recommended against the Bill, citing significant concerns about harms associated with both inappropriate medical use and recreational use.
It also noted that community views on decriminalisation of recreational cannabis remain deeply divided.
Despite this, it is widely accepted Australia’s medicinal cannabis products are of high quality and the industry faces stringent oversight.
Both the Office of Drug Control (in the Commonwealth Department of Health and Aged Care) and the Therapeutic Goods Administration (TGA) oversee complex regulatory regimes governing access to medicinal cannabis.
Due to the limited evidence of clinical efficacy, most medicinal cannabis in Australia is regulated differently from other pharmaceuticals.
Most medicines within Australia undergo a review process by the TGA which considers evidence of safety and efficacy before deciding whether they should be entered onto the Australian Register of Therapeutic Goods (ARTG).
Entry into the ARTG is critical to the drug producer.
It recognises that the regulator has found sufficient evidence to support the medicine’s use for the treatment of specified conditions, allowing manufacturers to sell them and doctors to prescribe them.
Currently only two cannabis-related products have been entered into the ARTG.
For other cannabis products, the lack of high-quality large scale clinical studies demonstrating safety and efficacy means they do not meet the criteria.
Instead, most medicinal cannabis products are only available via “exceptional access” pathways, requiring TGA approval on a case-by-case basis or via a medical practitioner who has received Authorised Prescriber accreditation from the TGA.
Many European countries have either relaxed, or are considering relaxing, laws permitting access to medicinal cannabis, with reports suggesting European supply of medicinal cannabis products is unlikely to be able to meet demand.
This creates major opportunities for Australian producers.
Australian regulators and exporters need to be very clear in managing the risk that their medicinal cannabis could not be hijacked into the illegal street cannabis market.
As a country uncertain about whether the benefits of legalising recreational cannabis outweigh the risks, can we ethically export medicinal products that may be diverted to recreational use that we ourselves are yet to accept?
If we can navigate this dilemma, Australia’s global reputation as a leader in pharmaceutical regulation is a significant bonus for producers.
By upholding rigorous standards for domestic production, we can ensure that our products meet the highest quality benchmarks, aligning with the expectations of international trade partners and delivering significant benefits to our farmers.
Dr Wendy Bonython is Associate Dean Learning and Teaching in the Faculty of Law at Bond University