Denmark’s six-year medical cannabis pilot scheme could soon be expanded into a fully legalised market, following a surprise announcement from the government last week.
The Danish pilot scheme has been running since 2018, and has continued to expand in both scope and patient numbers over the past six years, with four different access schemes now operating.
Following the publication of a comprehensive analysis of these programmes, Minister of the Interior and Health Sophie Løhde last week met with the parties behind the trial scheme to discuss plans to ‘make the scheme permanent’.
Danish medical cannabis oil producer Stenocare tells Business of Cannabis that while the structure of the new framework is not yet clear, it’s likely to see a significant expansion in the market.
“It is going to grow the market. Medicinal products are primarily prescribed by specialists, while the pilot programme allows medical cannabis to be prescribed by GPs, so their’s a larger pool of prescribers out there… I think we’ll see an increase in treatment,” its CEO Thomas Skovlund Schnegelsberg said.
What happened?
Last week, Ms Løhde announced for the first time that the government planned to extend the pilot scheme permanently.
In a press release, the Minister said that 1800 patients had accessed the various schemes over the last three years, collectively redeeming around 20,000 prescriptions.
This number has been steadily increasing, with prescription numbers now at their highest level since the start of the trial.
While various side effects have been closely monitored and reported by the health agency, ‘no new knowledge emerged that treatment with medical cannabis has negative patient safety consequences’.
As such, on behalf of the government, Ms Løhde invited SF, Liberal Alliance, Enhedslisten, Dansk Folkeparti and Alternativet to negotiations on the trial scheme on medical cannabis on November 19.
According to Mr Schnegelsberg, the announcement ‘was completely unexpected and came out of the blue’, following radio silence from the government on progressing the scheme throughout the year.
He explained that late last year, industry, doctors and patient organisations were contacted to provide input for the evaluation report, which was published alongside this announcement.
“At the time, there was a rush to gather feedback, suggesting an eagerness to move forward with the evaluation and make a decision based on it. Then, suddenly, everything went quiet. Many industry organisations and stakeholders reached out to politicians to ask what was happening, only to receive vague responses like, ‘It’s not a priority’ or ‘We’ll see what happens.’ That has been the tone ever since.”
Jeppe Krog Rasmussen, CEO of Danish medical cannabis operator DanCann Pharma, believes the announcement was a ‘matter of political strategy’.
He told Business of Cannabis: “The time now appears ripe for addressing the Pilot Programme on Medical Cannabis. This timing is, after all, reasonably appropriate, considering that the scheme does not formally expire until the end of next year (2025).”
The report
The evaluation report, which includes input from various industry stakeholders, provides a number of key recommendations that could point to how Denmark’s medical cannabis framework now develops.
Primarily, it recommends transitioning the four pilot programmes into a permanent cohesive framework by 2025, based on the positive outcomes of patients during the trial.
Currently, Denmark operates under four distinct frameworks for prescribing medical cannabis:
- Pharma Products: Includes drugs with marketing approval supported by robust clinical trial data (phases 1–3) like Sativex and Epidyolex.
- Pilot Programme Products: These include medical cannabis items approved under Denmark’s pilot program, including Stenocare’s oil range.
- Unlicensed Products: These are not formally approved but are available through special dispensations, like Nabilone and Marinol.
- Magistral Products: Custom-made by licensed pharmacies to meet individual patient needs when no other alternative is available.
The report suggests that this framework needs to be streamlined and standardised across all four schemes, while the licencing process for new products should also be simplified.
Spending and reimbursement was also a key issue, with the report suggesting that disparities between the schemes require an urgent review.
Currently, magistral products receive an 85% subsidy, while Pilot Programme products are subsidised at 50%, creating major inequalities across the scheme.
Mr Schnegelsberg commented: “From my perspective, based on the limited understanding I have of how politicians think and act these days, I would expect the discussion to focus on topics that impact the health budget. Politicians are likely to scrutinise whether the proposed changes might negatively affect the overall cost of medicine allocation within Denmark’s healthcare system. That will likely be a key area of political deliberation and decision-making.”
Cost-benefit analyses have also been recommended in the report to identify savings opportunities, amid suggestions that Denmark should leverage its regulatory reputation and begin generating revenue through exports.
Mr Rasmussen says he hopes that ‘the content of the framework will be revisited’ rather than simply made permanent, highlighting some key issues he believes should be addressed ‘to improve conditions for the entire ecosystem’.
Alongside streamlining the approval process and harmonising reimbursement, he hopes physicians will be given greater flexibility and reduced liability, citing an ‘unsustainable level of responsibility’ they currently face.
The report highlights the need for better education for prescribing doctors, along with updated clinical guidelines enabling doctors to prioritise specific products.
In a promising addition, it also recommends prioritising investment in research, including collaboration with international projects, the need for continued collaboration with patient groups, healthcare providers and industry representatives, and the need to strengthen the domestic cannabis industry in Denmark to expand options for patients.
Many of these more technical issues like the use of pesticides and how prescriptions should be defined, Mr Schnegelsberg suggests, are ‘more likely to be addressed by an expert panel outside the political system’.
A comprehensive evalutation of these considerations is now due to be published by the end of the year.
Impact on the market
With the details of the new framework still being hammered out by the government, the potential impact on Denmark’s domestic market is unclear.
However, as reported last week, the news has seen Danish cannabis stocks spike dramatically, suggesting investors believe expansion is imminent.
As its European counterparts like Germany, Luxembourg and Italy are witnessing a pushback against cannabis reform, Mr Schnegelsberg suggests politically there is little in the way of seeing this progress in Denmark.
“The government’s recent proposal to make the medical cannabis pilot programme permanent indicates a pragmatic approach, likely viewing it as an administrative matter rather than a contentious political debate,” he explained.
“This approach aligns with the government’s intent to streamline the process, allowing for a smooth transition from the pilot programme to a permanent legal structure for medical cannabis.”
“Given these benefits—reduced waiting times, increased access to treatment, cost savings for both patients and the healthcare system—it seems like a no-brainer. Politicians should easily recognise the value of these changes.”
From a business perspective, there is also considerable optimism regarding the upcoming changes. For Stenocare, this is likely to ‘result in increased sales’.
Mr Rasmussen added: “By implementing the adjustments outlined, we could unlock entirely new opportunities for the DanCann Pharma Group and the broader ecosystem, including patients, physicians, and others. As a company operating exclusively within the Danish context, achieving success in this regard is of paramount importance to us.”
The post New Era for Medical Cannabis in Denmark as Government Announces Plans for Permanent Legal Framework appeared first on Cannabis Health News.
Go to Source
Author: Business of Cannabis
