Update on the Danish medicinal cannabis pilot programme

The Danish medicinal cannabis pilot programme is planned to end this year after a four-year trial period. It is still to be decided at a political level how the future will look for the programme.

The four-year Danish medicinal cannabis pilot programme is coming to an end in 2021. Based on the experience gained from the programme, the Danish Government must decide the future of medicinal cannabis in Denmark.

The Danish Ministry of Health published its evaluation of the medicinal cannabis pilot programme at the end of November 2020, which led to a debate of as well as criticism of the programme among health professionals and experts within the field. Based on the Ministry’s evaluation, Magnus Heunicke, the Minister of Health, stated that, at the beginning of 2021, the Minister is going to initiate political negotiations in respect of the future of the pilot programme. 

Current status of the pilot programme 
The pilot programme enables general practitioners to prescribe medicinal cannabis to patients. During the programme, seven different products have been available for prescription. However, some of the said products have been “deactivated” making only four products available for prescription since 30 June 2020. Three of these products are herbal teas originating from the same company. The fourth product is a soft capsule product from another company. This means that only two companies have succeeded in having products admitted to the programme.

The product prices have been stable during the programme and vary from approximately DKK 783.50 to DKK 2,748.55 depending on the product in question. A reimbursement scheme was made effective as from 1 January 2019, and the reimbursement varies depending on the condition of the patient.

In the first 2½ years of the programme, 10,071 prescriptions of medicinal cannabis were dispensed among 2,550 patients. The most common conditions patients attempt to relieve by using medicinal cannabis are neuropathic pain, nausea, and vomit, as well as spasticity.

During the first 2½ years of the programme, the Danish Medicines Agency received 100 reports on adverse effects. Most of the adverse effects were already known and described in the product summary of approved medicinal cannabis products. Knowledge of adverse effects gained following the first 2½ years of the pilot programme has not yet been published.

A development scheme has been running concurrently with the pilot programme. The purpose of the development scheme is to provide an “experimental environment” for companies aspiring to enter the pilot programme. When the companies are ready to meet the requirements of the pilot programme, an application may be submitted. A total of 47 companies have been approved and entered the development scheme. However, four companies no longer hold an approval since they no longer meet the scheme requirements. 

 

Evaluation of the pilot programme by the Danish Ministry of Health
The evaluation conducted by the Danish Ministry of Health in cooperation with its underlying agencies was published on 30 November 2020 and is meant to provide a basis for political negotiations in respect of the future of the pilot programme and the destiny of medicinal cannabis in Denmark. 

The evaluation essentially concludes that the pilot programme provides a proper and safe framework for the use of medicinal cannabis, which was one of the main purposes of the programme to respond to patients’ self-medication by way of illegal products. 

However, the programme has met several challenges. Among these are limited and expensive product offerings and the medical practitioners’ reluctance to prescribe the products. The evaluation states that these factors have led patients to turn to the illegal cannabis market and self-medication. In addition, the evaluation points out that evidence of a positive effect of treatment with medicinal cannabis is still weak. In this context, the evaluation stresses the importance of the benefits of the medicinal cannabis products counterbalancing the adverse effects of the products.

As for the development scheme, the evaluation concluded that a smoother transition from participation in the development scheme to the pilot programme is asked for. 

The evaluation shows that patients’ associations and the cannabis industry wish for the programme to become permanent or to continue for an additional number of years before turning permanent. The evaluation refers to four possible scenarios when the pilot programme expires on 31 December 2021:

1. The programme will continue as evidence of positive effects is still needed
2. The programme will be made permanent
3. Part of the programme will continue and part of it will be made permanent. The programme will continue as far as prescriptions to patients are concerned, and the programme will be made permanent as far as cultivation and export of medicinal cannabis is concerned 
4. The programme will be terminated 

Dissatisfaction with the pilot programme 
The pilot programme has been the centre of heated debate. The programme is, for one thing, accused of referring more patients than before to seek out the illegal cannabis market as medical practitioners have shown reluctance to prescribe the products and due to the high prices, which is contrary to the political intentions behind the programme. Critics are even pointing to the fact that several medical associations have advised against prescribing medicinal cannabis as evidence of the benefits of the products is not sufficient. 

Critics have also taken a position on the evaluation of the pilot programme conducted by the Ministry of Health. The evaluation allegedly emphasises all the challenges and disadvantages of medicinal cannabis and only briefly refers to its benefits and advantages. The critics underline that specific focus on availability, price and product offerings is necessary going forward. 

Pending political negotiations concerning the future of the Danish pilot programme
Based on the evaluation of the programme, Magnus Heunicke, the Minister of Health, has stated that he will initiate political negotiations in respect of the future of the pilot programme at the beginning of 2021. The Minister wishes to conclude a broad political agreement with the support of as many of the political parties in the Danish Parliament as possible. Due to the COVID-19 crisis, the political negotiations have been delayed. 

Concluding remarks
As for now, we are looking forward to the political negotiations in respect of the pilot programme and to follow up on any developments. 

Please find a link to the evaluation of the medicinal cannabis pilot programme conducted by the Danish Ministry of Health (in Danish only).