Australia and New Zealand are undergoing contrasting reforms in their medical cannabis regulations. New Zealand aims to lower product quality standards for domestic producers to facilitate exports, while Australia seeks to elevate standards for international producers to ease imports.
According to Prohibition Partners’ ‘Oceana Regulatory Report 2024’, both countries share the common objective of leveling the playing field between domestic and international players. These regulatory shifts could enhance the competitiveness of Australian and New Zealand producers globally, making them key players in the evolving cannabis landscape.
Furthermore, despite existing regulatory disparities, the industries in both countries are evolving and likely to integrate, as New Zealand relies on Australian products for patient treatments.
Medical cannabis and its production were legalized in Australia in 2016, and the patient population has grown from around 20,000 in 2017 to ‘somewhere close to 600,000,’ with thousands more users thought to be accessing cannabis from illicit sources.
The rapidly expanding market is overseen by two federal authorities: the Therapeutic Goods Association (TGA) and the Office of Drug Control (ODC). Individual states have autonomy in implementing these regulations, but any doctors seeking to prescribe ‘unauthorized’ medical cannabis medicines must seek approval from the TGA in most jurisdictions.
Medical practitioners can import and prescribe unapproved cannabis medicines via the ‘Special Access Scheme (SAS) on a case-by-case basis or become an ‘Authorized Prescriber’ (AP). APs can prescribe medicinal cannabis products without notifying the TGA each time within the five-year approval period.
Since 2021, both SAS and AP submissions for unapproved products have been based on categories set by the treatment’s cannabinoid content, offering prescribers flexibility if supply chains are interrupted.
The TGA sets the Therapeutic Goods (Standard for Medicinal Cannabos), or ‘TGO 93,’ which determines the minimum quality requirements for unapproved medical cannabis products. In March 2022, significant updates to the TGO 93 were implemented, making it mandatory for medical cannabis imports to meet EU GMP requirements as of July 1, 2023.
Prior to this amendment, Australia’s domestic producers were forced to compete with cheaper medical cannabis imports. These new amendments have leveled the playing field for domestic producers, creating a homogenized import market.
New Zealand allowed access to imported non-pharmaceutical medical cannabis products in 2016, with Sativex available for multiple sclerosis treatment since 2008.
Under the initial scheme, doctors needed approval from a government minister to prescribe cannabis products on a case-by-case basis.
However, the system was overhauled in 2020 with the introduction of the ‘Medicinal Cannabis Scheme.’ The scheme established quality standards, a licensing scheme, and amendments enabling doctors to prescribe without seeking approval from the Ministry of Health.
Now, further changes to the regulatory framework are being worked upon by the authorities, expected to finish in ‘early 2024.’
The main consequence of these changes is to facilitate easier export of products, allowing domestic producers to achieve better economies of scale and lower the price of treatment for patients in New Zealand.
These changes will enable the export of cannabis seed, starting material, cannabis-based ingredients, and medicinal cannabis products for testing, analysis, and research.
They will also remove the requirement for consignments of starting material to meet the minimum quality standard before export and remove the requirement for cannabis-based ingredients to meet minimum requirements if manufactured to GMP standards.