European medical cannabis will shift from capricious flowers to quality oils as patients seek consistent and reliable medicines.
Some manufacturers looking to supply Europe with competitively-priced medical cannabis are preparing for this shift. And, one Colombian cultivator says such a switch would have major benefits in the German market – Europe’s premier medical cannabis country.
A Process Of Decay
He said: “Producing cannabis medicine from flower is inherently challenging. One plant is different from the other, and cannabinoid concentrations vary from batch to batch even with same genetics.”
“THC content is very sensitive to light, and changes over time; if you store the flower for a few months it has a lower THC content from what it was at the outset, and that’s not easy to fix.”
“It’s a process of nature, of decay, so we believe the pharmacies and the medical community, ultimately, when they have the ability, will switch to extracts. Clinicians require precise dosing, extracts allow them to do that, and are, we believe, the way forward.”
He highlighted how in the recreational area the march of oils is unstoppable as the source material for tinctures, gummies, drinks, cosmetics and the like.
Just Seven Tons Of Imports
FoliuMed’s aim is to deliver competitively-priced medical cannabis into Europe which is predicted to be the world’s leading market. Prohibition Partners estimate that as the continent eases restrictions on medical cannabis it will grow to be worth up to €123 billion by 2028.
The market is quite small at the moment with Germany – Europe’s largest market – importing just seven tons in 2019, while Canada had an oversupply of 500 tons at the end of last year.
However producers are preparing for its projected growth with around a dozen Canadian firms achieving the European Union Good Manufacturing Practice (EU-GMP) standards needed to supply Europe. FoliuMed believes its competitive advantage is the ability to grow in a low-cost environment – Colombia – while processing in compliant European facilities.
In order to achieve this it has secured the required standards at its growing facilities, near Bogota, and has has formed a joint venture with a German pharmaceutical firm to process imported extracts.
EU-GMP Secured In Germany
Once in Germany they will undergo further processing to align with EU-GMP regulations in the pharmaceutical company’s labs. EU-GMP is necessary to sell into the European market, but also fairly difficult to achieve.
Mr Zugel said: “EU- GMP is the gold standard for manufacturing pharmaceutical products, and requires lots of time, effort and money. It means that you need an integrated quality management system which delivers precisely the same product according to specifications in every production run, and can deliver a shelf-life suitable for sales through the pharmacy channel.
“Low-cost countries haven’t managed yet to produce meaningful volumes of GMP certified product, which paradoxically results in severe supply shortages and high prices in Europe despite the overhang in Canada and other markets… which in turn keeps the black market going.
“We believe that extracts will be the next wave of medical cannabis products replacing flower, and those are much easier to standardise than flower and comply, therefore, with EU-GMP.”
From Seed To Sale
“But, building a GMP capability on your own is challenging, and more so when you have your grow and extraction in a region of the world where highly-skilled quality management professionals are hard to come by.”
“For this reason, we at FoliuMed decided to enter an upstream joint venture with our German partners who have the experience to build and manage the system from seed to sale.”
Elaborating on the difficulties in growing cannabis medicine, he continued: “Cannabis seeds and flowers are inherently variable, and perfect standardisation in the grow methods and climate control is very hard to achieve.
GMP is, as its name says, is related to manufacturing, which only comes into play for the post-harvest drying, processing and packaging steps.
“However, if your source material is inherently unstable and varies by each harvest, by definition you can’t get a GMP certified flower from it even if your processing complies with the standard.”
Evolutionary Plant Genetics
There are further difficulties for cultivators in evolutionary plant genetics, says Mr Zugel. He continued: “On top of this is genetic drift; the changes in the composition of plants and their offspring over time.”
“Think about it like some form of accelerated Darwinism – with cloning, you can create over 20 generations from the same plant within a year, which in human terms would equate to a 1,000 year period. Humans, on average, grew by nearly 10% over that period, and more than doubled their life expectancy, and it’s no different with plants.”
Mr Zugel is German-born and his home market – with some 80,000 patients – runs, by far, the most successful medical cannabis program in Europe. However, the delivery process for medical cannabis flower has it own peculiarities with patients either rolling their own joints of ground dry-flower or using a medical vaporizer.
While most medical cannabis patients in the U.S. prefer joints, it has been ruled out of the prescription process elsewhere in Europe.
Pharmacists’ 100% Mark-Up
The second method is through a vaporiser device of the kind made by Storz & Bickel, which was bought by Canadian firm Canopy Growth in 2018. This cumbersome table-top, cone-shaped device costs hundred of Euros and produces a smoke which fills a balloon for inhaling.
He said: “These are not sustainable long-term ways of delivering a medical application. But that’s how its done, right now, and is why the flower as the medical delivery method will ultimately be replaced by oils.”
Whilst oils are currently used in Germany a pharmacist must have some input – garnering a 100% mark-up for their efforts. This hands-on approach permits the cannabis oils to be sold with a doctor’s prescription without needing to go through the lengthy and expensive clinical trials required for other medicines.
With oils up to five-times more expensive than flowers and the latter out-numbering the former in German usage by 80% to 20%, FoliuMed hopes to turn this on its head – and allow medical cannabis users to ditch their joint-rolling paraphernalia and cumbersome vaping devices.