EXCLUSIVE: The Department of Health is considering taking steps to require all imported medical cannabis products to be manufactured according to Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP) quality standards, according to formal correspondence with a medical cannabis licence holder seen by Cannabiz.
According to the Department, consultation on these reforms is expected to commence before the end of 2020.
Cannabiz has learned a company licensed by the Office of Drug Control (ODC) recently presented a letter to Federal Minister for Health Greg Hunt describing what they say is an uneven playing field, with locally made products held to higher quality requirements than imported products.
Currently, products imported from overseas are required to conform with Therapeutic Goods Order 93 (TGO 93), the medical cannabis quality standard administered by the TGA. But they are not always required to be manufactured in a GMP-licensed facility.
A TGO 93 declaration is required for any finished-dose-form product as well as cannabis plants and ingredients used in the manufacture of products.
This differs to products made locally, which must – like all Australian-manufactured medicines – be made according to GMP quality standards. This inequality between local and imported products has been a source of tension in the sector for some time.
The Department of Health has assured the licensed company that it is likely to propose amendments to TGO 93, requiring all imported products to be manufactured “in accordance with GMP requirements”. This would be followed by a consultation period and a decision could be finalised in the first half of 2021.
Such an amendment would transform the landscape of medical cannabis in Australia which has been characterised by fierce price competition between non-GMP imported products while local cultivators and manufacturers have struggled to find their feet.
It is not yet clear how many products currently available in Australia could be affected, or what impact this might have on product pricing and affordability.
Industry leaders have welcomed the news.
CEO of Cymra Life Sciences Joel Hardy said: “This is the right step for the cannabis industry to remove the inequitable pharmaceutical quality standards between Australian manufacturers and lower quality international imports.”
At this stage it is unclear if amending TGO 93 could also restrict the import of non-GMP purified cannabinoids (Active Pharmaceutical Ingredients, or API) used in local manufacturing and extemporaneous compounding.
In some Australian states, it is becoming increasingly common for doctors to write a prescription for a compounded cannabis product. Patients take this prescription to an appropriately licensed pharmacy where a product is made by the pharmacist for that patient on-demand using imported API.
This pathway is attractive because it bypasses the Special Access Scheme entirely and no TGA-approval for prescription is required. At least some of the API used in these compounded preparations do not meet GMP standards.
CEO of LeafCann Group Elisabetta Faenza welcomed a level playing field for all products: “We would expect this to not only apply to finished products but also biomass, dried buds and API,” she said.
Medipharm Labs CEO Asia Pacific Warren Everitt added: “The original sentiment to allow imports was to satisfy patient demand. Australian companies can now satisfy that demand under the stringent quality standard of the TGA.”
When asked to clarify the potential impacts of amending TGO 93, a spokesperson for the Department of Health said: “Given that we are some months away from conducting a consultation on this, and have not yet drafted a consultation paper, it is premature to speculate on the options that will be put forward for feedback.”