By Bill Griffin, Special Contributor to New Frontier Data
Germany potentially offers the largest medicinal cannabis market in Europe. The most populated member nation in the European Union (EU) has been granting safe access to patients since March 2017. According to data recently shared by the German government, there were 27,000 prescriptions processed in 2017 and 95,000 processed throughout all of 2018, effectively tripling the market before its third anniversary.
Such numbers reverberate within the industry buzz as more companies seek to move into the German market. It is worth reviewing how the system functions in practical terms.
By rule, cannabis cannot be a patient’s first choice among prescriptions. Instead, patients must have tried other medicines before having cannabis prescribed; indeed, it likely would be the final therapy after all other options’ having failed or presented adverse effects. Patients need also meet certain criteria in order to qualify for medical cannabis as a medicine — chiefly to demonstrate that they suffer from some form of chronic pain.
Each patient’s doctor will need to specify the respective brand and strain allowed for consumption, though a pharmacy may be consulted regarding prescription advice and availability. Once given, a prescription will expire after 10 days (reinforcing the need for confirmation of availability).
Likewise, it shall be incumbent upon one’s doctor to choose the best among flower or tincture for the prescription, and to advise the patient about how best to consume it.
Any German pharmacy will be obligated to honour such prescriptions, and be connected to a national supply network. For now, 60% of orders from pharmacies are fulfilled via fax, though some estimate that rate to reach 80%.
The cannabis supply is sourced and distributed by companies which hold the necessary licenses to do so: Specifically, a GMP- and GDP-certified importer in Germany needs to hold a manufacturing and importation authorization (MIA) per Sec. 13, 72 AMG, as opposed to a wholesale distribution authorization (WDA) per Sec. 52a AMG, and finally a licence for the trade in narcotic drugs Sec. 3 of the Betäubungsmittelgesetz (BtMG), Germany’s controlled-substances law.
As Benedikt Sons, CEO and co-founder of Cansativa explained it as a bulk importer and distributor to the German market, “if an importer wants to import products from a non-EU country, for example Canada, a [MIA] is required as they will bring the products to market as the legal manufacturer.”
With an insistent gap in the model being the pressing need to educate doctors about the dynamics of product options, strengths, and availability, they can gain awareness of brands and products through conferences or direct-mail brochures. Opportunities for outreach regarding products’ differentiation and advantages for patients could prove to be particularly advantageous.
There is a rule in Germany that cannabis cannot be sold as a finished product. There must therefore be an interaction from the pharmacy before a product can be distributed to the patient. It could be as simple as a pharmacist’s opening the container and grinding dried material, or as complex as formulating a custom tincture. An unfortunate consequence of the requirement is that it passes additional costs to patients, who may or not qualify for coverage from their medical insurance. Such an add-on cost is not incidental; for flower, for example, it could cost as much as €24 per gram with a monthly limit of 100 — a potential upcharge of €2,400 per month.
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