Most people wouldn’t know that we are the only country in the world allowing imported medical cannabis products into Australia that do not meet Good Manufacturing Practice (GMP) international standards. Based on the huge increase in SAS-B products available, there is a real risk of inferior products adversely affecting patients. Cymra Life Sciences co-founder Joel Hardy
The current system also negatively impacts local manufacturers who have to comply with GMP rules, which adds costs and gives importers an unfair advantage.
The Therapeutic Goods Administration (TGA) is currently considering
submissions on the topic. Writing in Cannabiz recently, editor-at-large Rhys Cohen outlined the options being considered by the Government.
“The Department of Health wants to ensure a level playing field for everyone by imposing similar quality standards on both imports and local products. They have proposed two possible solutions (other than ‘doing nothing’).
“The first is to insert new GMP requirements specific to medicinal cannabis in the Therapeutic Goods Regulations, and the second is to do essentially the same thing but by making changes to TGO93.
“The only meaningful difference between these options seems to be that amending the regulations would still allow for some non-GMP ingredients to reach Australian patients through compounding pharmacies, while amending TGO93 would be more comprehensive.”
Through my discussions with stakeholders, I am not sure patients and doctors are aware of TGO93, the lower threshold for imported ingredients for medical cannabis products.
It’s a new standard that was created to increase supply for desperate patients and meet rapidly rising demand. However, the form for importation is a self-declaration (think self-policing), with testing for stability, specifications and standards able to be conducted locally, presenting a potential risk to patients consuming imported products.
If changes are made to level the playing field, it is true that some patients may not be able to access their preferred brand. However, there would be a transition period to enable the affected brands to achieve GMP standards.
In 95% of cases, ingredients can be replaced with an exact or very similar product or formulation that is GMP standard for the same price because competition remains high.
Lastly, it’s hard to estimate what effect such a move would have on prices immediately, but there are many domestic companies with existing supply that can scale, and there are still GMP-quality medicines that can be imported. I believe prices will continue to stay cost effective as companies vie for market share, even if some choose to exit.
Lucy Haslam, founder of patient advocacy group United in Compassion (UIC), says: “Australian patients have had to battle for the legal right to access medicinal cannabis. Currently, they are provided with potentially inferior and dangerous products via the legal pathway that was created to protect them from the harm associated with unregulated access.
“UIC believes that patients deserve high-quality GMP products from the domestic and international industry.”
The existing system means that Australia lets product in then audits what’s on the market.
Using the current standards, the TGA and Office of Drug Control (ODC) have a lot of enforcement and policing to do.
With more than 150 products on the market, this is a huge regulatory burden which cannot be maintained with current budget estimates and staffing.
It’s also a patient safety risk, as medicines are on the market and will need to be recalled if any adverse events occur.
Making GMP requirements universal allows for the exchange of regulated products without requiring an ODC permit for each transfer, saving even more time.
Self policing would occur to a worldwide, commonly-held standard with quality assurance between cultivators, manufacturers and distributors maintained.
The threat of fines, or losing your GMP licence altogether, would be a serious consequence of failure. Could there be bad actors? Sure, but it’s a lot less likely than under the current system of self declaration.
Australia has some of the best conditions in the world to be a cannabis powerhouse and companies that can thrive in the right environment.
We have a top-tier medical system respected by the world, R&D tax rebates, an ideal agricultural environment, skills, innovation and renowned, high-quality products.
But without a level playing field for domestic producers, how can the industry compete? If this was allowed in any other agricultural industry there would be an outcry from our farming community, as there should be.
An inability to compete means less demand for Australian companies, who need scale to be efficient and reduce prices, but it also means fewer jobs.
“Without a level playing field for domestic producers, how can the industry compete? If this was allowed in any other agricultural industry there would be an outcry from our farming community, as there should be.”
At a time when unemployment for young and regional Australians is high, this really matters.
Companies like ANTG, Little Green Pharma and Cannatrek, which have set up fully domestic operations, are impacted. But think also of those companies trying to get there who are being stymied by unfair competition.
ANTG COO James Gaskell says: “As a 100% Australian-operated company, we believe that without a consistent quality framework for imports there will be an unfair advantage that will continue to negatively impact the growth of the Australian cannabis industry.”
If local demand increases, so does supply, and price drops further for patients. It also allows Australian companies to export cost effectively through economies of scale.
Australia is the only country in the world with a medical cannabis program that is allowing non-GMP importation. Canada and the US don’t allow any imports for commercial sales. Germany, the UK, Brazil and Denmark only allow GMP medicines to enter their country.
Why are we, with a smaller population, different from nearly everyone else?
The current TGO93 system has reached its limit. I just hope the TGA sees it that way.