In August 2016, PharmOut tendered and won a contract to assist a client to obtain a Therapeutic Goods Administration (TGA) Good Manufacturing Practice (GMP) Licence for a manufacturing facility, and in April 2017 they received their licence. This was not an unusual assignment as we routinely assist manufacturers with GMP licensing around the world. However after four years, we should reflect on our journey and experience working to modern pharmaceutical GMPs and how to bring high quality, safe medicines to patients at affordable prices.
The table below (extracted in August 2020) tells a story of an industry ready to invest – the size of this proposed investment astonishes me. Through the application process to achieve Main Project Status (MPS) the Medicinal Cannabis industry has declared in formal, considered submissions to the Australian federal government, that they will be investing close to A$3.3bn and creating over 3,000 new direct jobs. This excludes numerous facilities below the benchmark to achieve MPS, or the A$50m investment project announced on the 1st June by the Canadian company Valens.
Why all this interest in cannabis?
Well, it’s big business. If you take a state like Colorado, medical sales in the month of June 2020 exceeded US$40m, whilst retail sales exceeded US$158m. The forecast is that it will exceed US$2bn in 2020. As an aside in 2019, the state passed a milestone with over a US$1bn of taxes being collected. Adjusting for population sizes and doing some simple maths (Colorado 5m and Australia 25m), this could be a $10bn industry in Australia, should Australia follow a New Zealand debate/referendum, and similarly hold a referendum on the permitting the legalisation of cannabis in Australia.
Growth in the Australian Medicinal Cannabis Industry
Aside from the “adult use” market, there has been tremendous growth in the Australian Medicinal Cannabis market. Based on the year-on-year growth using data released by the TGA, in July there were 5564 new SAS B approvals, with an increase of over 250% from July 2019. The month-on-month growth from June to July 2020 was made up of over 900 new patients, which is the largest single month-on-month increase on record.
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