Denmark's medical cannabis program suffered a setback in 2019 when it was discovered that batches of cannabis oils had been produced in unapproved facilities, leading to a suspension of the program. However, the program is back, and patient numbers are expected to improve rapidly. This marks the start of a new four-year trial period for medical cannabis in the European country.
After a strong start and with patient numbers reaching 2,000 in 2019, the Danish medical cannabis program came to a halt after the oil-based products supplied by the national company Stenocare were withdrawn from the market. Now, after an absence of two and a half years, medical cannabis oils are back in the Danish medical cannabis program, which should give a boost to the ailing scheme.
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With the number of medical cannabis patients now down to around 1,500, it is expected to start increasing again as people who prefer cannabis oil products are able to obtain their preferred medicines again. Stenocare CEO Thomas Skovlund Schnegelsberg says the new product should be available to patients in the first quarter of this year, subject to international import and export certificates.
He said, “This announcement strengthens our position as the first and only supplier of medical cannabis oils to the Danish pilot program. It underlines our position as the undisputed market leader in Denmark.”
The challenge for many patients in recent years is that only three products containing cannabis in flower have been approved by the Danish Medicines Agency (DMA) and made available to patients.
Products in oil form, therefore, offer a real method of administering medical cannabis for patients.
The re-entry of the oils into the program also marks the start of a new four-year medical cannabis trial period and comes as new rules allow domestic companies to grow cannabis and produce cannabis-based medicines beyond the end of the new trial period in 2026.
Conor O’Brien, an analyst at Prohibition Partners, believes these developments will give a boost to medical cannabis patients in the Scandinavian country.
He said: ‘The exit of Stenocare oils from the experimental program in Denmark has had a significant impact on the cannabis industry. Many patients started to source medical cannabis from compounding (extracts and isolates prepared in pharmacies) or turned to pharmaceuticals like Epidiolex when it came on the market in 2020.”
“However, many patients appear to have left the legal cannabis market after the loss of cannabis oils from the pilot program, with the number of patients falling by more than 20% 12 months after the event. The reintroduction of the oils will be a welcome development for many patients in the country, although it remains to be seen how many patients will return to using the oils after switching to alternative treatments.”
The disruption to the supply of medical cannabis oils in 2019 is the result of Health Canada identifying that several batches purchased by Stenocare from Canadian producer Canntrust had been grown in unapproved facilities.
Health Canada subsequently suspended parts of Canntrust’s license, which led Stenocare to end its collaboration with Canntrust and stop medical cannabis imports.
Schnegelsberg said medical cannabis patient numbers rose quickly from 300 to around 1,100 after the introduction of the oil-based medical cannabis products, boosting Stenocare’s sales in the first five months of 2019 to 4.4 MDKK (around €600,000).
No other oil-based medical cannabis products have been approved by the DMA in the meantime and Stenocare is currently working with the DMA to get two more oil-based products approved for the pilot program: a CBD oil and a THC-CBD blended oil.
Schnegelsberg added: “The Danish regulatory regime is known to be by far the most difficult to pass in Europe. We only managed to do this because of the experience of our regulatory team and the ability of our supplier, AgMEDICA Bioscience, to meet the medical cannabis requirements of the Danish Medicines Agency.”
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(Photo by Jose Luis Sanchez Pereyra on Unsplash)
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