Denmark: Four-year Danish Medicinal Cannabis Programme

Four-year Danish Medicinal Cannabis Programme

Four-year Danish medicinal cannabis programme

On 1 January 2018, a four-year medicinal cannabis pilot programme was introduced in Denmark. The programme is regulated by the Danish Act no. 1668/2017 on the Medicinal Cannabis Pilot Programme, as amended.

The products comprised by the programme are cannabis products intended for medicinal use. The products may be in the form of dried cannabis flowers, cannabis oils, capsules, tablets, etc., originating from the plant Cannabis sativa L.

The cannabis products included in the pilot programme are not authorised medicines. Typically, the products are not tested in clinical trials, which means doctors do not have the same knowledge of effects and side effects compared with authorised medicines. As part of the programme, doctors must take full responsibility for the product they prescribe and determine the dose for the individual patient.

Treatment with medicinal cannabis should not be tried before the patient has first tested relevant authorised medicine with an insufficient result.

The cannabis products must meet established requirements for cultivation of the plant and the manufacturing of the cannabis product. It is also required that the cannabis product is standardised and consistent, meaning that the manufacturer must be able to document the content of the product, so that strength and quality is the same for all packages.

In January 2018, when the programme started, only cannabis produced for medicinal use could be imported. From 1 July 2018, businesses were also allowed to cultivate cannabis and thus produce Cannabis Bulk and Cannabis Primary Products from Danish-grown cannabis.

All company activities according to the programme must be authorised by the Danish Medicines Agency, i.e. cultivating cannabis, producing and distributing cannabis bulk and cannabis primary products or cannabis inter-mediate products.

Four-year development scheme

In parallel with the programme a four-year development scheme was also introduced. According to the development scheme, the Danish Medicines Agency authorises research and development activities in terms of cultivating and handling cannabis, which may form part of the pilot programme at a later stage.

Activities according to the development scheme must demonstrate that the produced products are consistent and standardised subject to the required quality and may form part of the medicinal cannabis programme or the manufacture of medicinal products. Company activities according to the development scheme must be authorised by the Danish Medicines Agency.

The national competent authority

The Danish Medicines Agency is the competent national authority for implementing the programme and the development scheme and is an agency of the Danish Health Ministry.

The authority is responsible for

  • drafting regulations to help implement the programme and the development scheme as decided by

    the Danish Parliament

  • granting authorisations to companies according to the programme and the development scheme

  • supervision of companies authorised according to the programme and the development scheme

Import and export activities

Until 1 January 2019, companies were allowed only to cultivate cannabis in Denmark or import primary products. Further, only cannabis end-products could be exported.

As of 1 January 2019, cannabis manufacturers have also been allowed to export Danish-grown cannabis bulk and primary products and not only cannabis end-products.

Exporting activities relating to cannabis bulk or primary products must be in accordance with the relevant requirements in the legislation on the pilot programme, including

  • required authorisation
  • the country receiving the cannabis bulk must allow import of cannabis for medicinal use
  • the company importing the cannabis bulk or primary products must have the necessary authorisations in place according to national requirements in the importing country.
  • The export requirement has been a significant change in the programme and allows companies to engage in production on a large scale.

Ban on advertising

It is illegal to advertise for cannabis products covered by the programme. According to the legislation on the Medicinal Cannabis Pilot Programme it is prohibited to advertise for:

  • cannabis end-products
  • cannabis intermediate products included on the published list of cannabis intermediate products
  • cannabis primary products included on the published list of cannabis primary products

The advertising of cannabis end-products includes any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of cannabis end- products. A cannabis end-product may be produced by a pharmacy or a hospital pharmacy from a cannabis intermediate product according to a doctor’s prescription for a specific patient.

The advertising of cannabis intermediate products and cannabis primary products admitted to the list of cannabis intermediate products and cannabis primary products includes any form of door-to-door information designed to promote the supply and sale of cannabis intermediate products and cannabis primary products intended for use in cannabis end-products.

The ban applies to any form of advertising of cannabis end-products, cannabis intermediate products and cannabis primary products covered by the programme.

Evaluation and future plans

It is expected that the Danish medicinal cannabis industry will grow and evolve.

The programme and the development scheme run for four years until 31 December 2021 and is intended to provide a better basis for assessing the use of medicinal cannabis at the end of the trial period.

The Programme will be evaluated throughout its duration to determine whether it should be extended or made permanent.

Martin Draebye Gantzhorn
Partner

T +45 72 27 36 36
M +45 25 26 36 36
E mdg@bechbruun.com

Gundula Kjaer
Senior regulatory affairs manager

T +45 72 27 34 63
M +45 25 26 34 63
E gmk@bechbruun.com