In January 2018, a new statutory pilot programme on medicinal cannabis came into force in Denmark. The purpose of the pilot programme is to establish a safe framework for the use of medicinal cannabis in the Danish healthcare system.
Essentially, it provides physicians with a possibility of prescribing certain types of cannabis-based products for medicinal use in specific cases.
The pilot programme primarily concerns cannabis- based products imported from EEA member states and allows import and manufacture of so-called cannabis primary or cannabis intermediate products which technically are different from medicinal products subject to the grant of a Marketing Authorization. Under the pilot programme, a primary product may also legally be transformed into an intermediate product by an authorized manufacturer. Subject to being prescribed by a physician to an individual patient, the intermediate product will then undergo a labelling procedure at the pharmacy. Hereafter, the final cannabis end product may be dispensed for the treatment of patients.
Further, a separate development programme will run parallel to the pilot programme making Denmark one of the first countries in Europe to allow growing of cannabis for medical use. The purpose of this programme is to allow companies to provide intermediary products to the pilot programme.
Both programmes will run for four years. Based on the experiences, an overall evaluation of the programmes will then be made with a view to making a political decision about a permanent medicinal cannabis scheme in Denmark.
Consequently, for the next four years, Danish companies can grow, import, and manufacture cannabis for medical use if they obtain the appropriate (time limited) authorizations from the Danish Medicines Agency (the DMA).
The DMA's website contains guidance for manufacturers and importers on how to apply for such authorizations to import primary products or intermediate products and/or to manufacture imported primary products into intermediate products or to grow cannabis for medical use.
Doctors may hesitate to prescribe medicinal cannabis
As the treatment of patients with medicinal cannabis is subject to a prescription from a physician, the DMA has as part of the pilot programme issued a new set of guidelines on treatment with medicinal cannabis addressed at the physicians. Among other things, these guidelines outline the possible therapeutic indications, which the DMA assesses to be eligible for treatment with medicinal cannabis.
However, even under the new trial programme, physicians prescribing medicinal cannabis must take full responsibility for the prescription, including for any possible side effects of the medicinal cannabis, because it has not been authorised by the DMA. Consequently, the efficacy and adverse reactions of the medicine have not been tested to the same extent as medicinal products with a marketing authorization, and as the scientific basis of medicinal cannabis remains insufficient, many doctors may still be reluctant to take such responsibility and prescribe the cannabis-based products.