DANISH patients will be able to access medical cannabis for another four years after politicians agreed to extend a nationwide trial.
And, companies in the Scandinavian country producing cannabis for medical purposes are also to be allowed to operate permanently.
Denmark’s medical cannabis pilot programme had been due to finish at the end of December 2021 following a four year trial period.
But a broad majority of parties in the Danish parliament have voted to allow doctors to continue to prescribe medical cannabis products to their patients until at least the end of 2025, and make cultivation and production of medical cannabis permanent to safeguard investments already made in the burgeoning industry.
Fifteen Growing Operations
Some 47 cannabis companies have been licenced and around 15 have moved on to building facilities and growing crops.
The news bolsters Denmark’s ambition to become a leading player in the medical cannabis field as it ultimately looks to serve both the home and international markets.
The decision has understandably been welcomed by the few EU Good Manufacturing Practices-certified (EU-GMP) producers approved to supply Denmark’s medical patients – which include Netherlands-based Bedrocan and Canadian firms Aurora Cannabis and MediPharm Labs Corps – as well as others working in the industry.
Marianne Hundtofte Nielsen, vice president Business Development and Director Medical Affairs, Aurora Europe, told BusinessCann: “In its fourth year of the initial pilot programme, we believe the patient benefit has been realised. It is Aurora’s commitment to provide consistent, high quality pharmaceutical-grade products.
“The permanent authorisation for licenced producers of the production and export of medical cannabis in Denmark, independent of the pilot programme, is an important milestone recognising this young industry.”
Jeppe Krog Rasmussen, chief executive of DanCann Pharma, a Danish medical cannabis company added: “Perhaps the biggest risk associated with our business and our basis of existence is now eliminated.
“We applaud the Danish Parliament’s decision to extend the pilot programme that allows local cultivation and production of medical cannabis. The overall agreement is good news for the entire Danish medical cannabis industry and ecosystem as it is likely to attract further investments and stimulate the drive towards making Denmark a leading nation within the field of medical cannabis.
“Now the industry – and we as a company – can calm down and start creating further investments, development, and earnings.”
Patient Access Needs To Improve
Thomas Skovlund Schnegelsberg, CEO of Stenocare, which had approval to have medical cannabis oil and capsule products accepted for the pilot programme, confirmed the agreement is good news and would likely attract further investments and stimulate the drive towards making the country a leading nation within high quality medical cannabis.
He said: “With this decision, Denmark is now on a path to becoming a leading producer of medical cannabis for patients in Europe and be an important part of the hyper-growth expected in the coming years.”
But Mr Rasmussen sounded a note of caution. “With that said, we must not forget our Danish patients. Despite another four-year trial period with the prescription of medical cannabis in Denmark, nothing has changed in the legal framework regarding conditions. This is just not good enough.”
Denmark launched its initial four-year pilot programme in 2018 to offer patients legal, safe medicinal cannabis products, and to provide national health agencies with patient data with the aim of better understanding usage and efficacy at the end of the trial period, with a view to possibly establishing a permanent medical market.
The latter has not been mentioned, however, as part of the extension to the pilot scheme, which is currently only eligible to patients suffering from multiple sclerosis, spinal cord damage, neuropathic pain and cancer.
Four Products Allowed
The Danish government will now present a bill in the autumn ahead of its expected adoption before the end of 2021. As part of that the parliament will debate the levels of patient cost coverage or refund.
To financially support patients in the programme, a grant was set-up to cover their ongoing costs.
Terminally ill patients receive 100% reimbursement for their medical cannabis treatment. All others get a 50% reimbursement for up to DKK 20,000 per year.
These credits are automatically applied at the pharmacy at the time of dispatch. However, once patients meet their reimbursement limit, they must pay for the treatment out-of-pocket, which has made medical cannabis access difficult for many.
Currently only four imported products are registered for use on the pilot programme, including Sedemen Aurora Nordic Cannabis, Bedrocan CannGros, and Stenocare CBD Drops.
The numbers of patients benefitting from the pilot programme has fluctuated since its launch in 2018. Until mid-2019 around 1,000 patients were receiving 1,800 prescriptions per quarter. But the number of patients sharply declined in the second half of 2019. In the second quarter of 2020 the figure had dropped to 408.
So far the programme has had 2,550 patients.
Aurora To Supply Danish Cannabis
Aurora was one of the first companies to invest in Denmark in January 2018 – at the beginning as a joint venture – and today as a fully owned subsidiary of Aurora Cannabis Inc.
In November 2020, the company successfully delivered the first Danish produced supply of GMP certified medical cannabis to the German market.
With more than 9,200 m2 production space and an output of a maximum of 10,000 kg of pharmaceutical-grade medical cannabis per year, Marianne Hundtofte Nielsen said Aurora Nordic is well positioned to service the Danish, European and international markets.
Looking ahead she said Aurora Nordic is working closely with the Danish Medicines Agency to offer a number of treatment options, such as extracts and dried flowers, to Danish physicians and patients, as part of the cannabis pilot programme.
In the course of 2021, Aurora will transfer from imports from Canada to Danish production. Dr Axel Gille, President of Aurora Europe, said: “The transfer of production to our Danish site enables us to deliver faster and more reliably while maintaining the same quality and consistency.
“Our goal is to supply the growing medical cannabis market in Europe with well-known and proven prescription drugs from our own EU-GMP production facility in Denmark, and this is an important step in achieving that.”