Cannabis - The Pilot Programme and The Development Scheme

Published 08 October 2019 by Holst, Advokater

Since 1 January 2018, Danish doctors have had the opportunity of prescribing cannabis products for their patients; A four-year medicinal cannabis pilot programme has been introduced in Denmark implying that licences for importing cannabis for Danish patients can be issued. Today it is also possible to cultivate, produce and distribute medicinal cannabis in Denmark. In parallel to the pilot programme, a development scheme has been introduced making it possible to apply for cannabis cultivation and handling licence with a view to producing cannabis suitable for medicinal use.

The schemes have entailed the creation of hundreds of new jobs in Denmark, and the production of medicinal cannabis is expected to become an important export article.

Background

On 1 January 2018, a medicinal cannabis pilot programme was introduced in Denmark together with a development scheme for the cultivation and handling of medicinal cannabis.

The pilot programme and the development scheme were introduced in the course of a political agreement between the majority of parties in the Danish Folketing in order to set a framework for medicinal cannabis produced for an individual patient and prescribed by a doctor. The purpose was to ensure, among others, that some of the patients self-medicating themselves with illegal products could have a legal alternative, and to ensure that use of cannabis is subject to a safer framework within the Danish Healthcare System (Sundhedsvæsenet).

During the pilot programme, which runs from 1 January 2018 until 31 December 2021, an evaluation will be made of the programme in order for the politicians to decide on any permanent medicinal cannabis scheme, including the options of continued cultivation of cannabis for medicinal use in Denmark.

The pilot programme

Since 1 January 2018, Danish doctors have had the opportunity of prescribing cannabis products for their patients. From the same time, it became possible to obtain a licence to import cannabis for Danish patients in the pilot programme.

Since 1 July 2018, it has also been possible to apply for a licence to cultivate medicinal cannabis in Denmark for inclusion in the pilot programme and apply for authorisation to export medicinal cannabis.

The development scheme

On 1 January 2018, it became possible for companies to apply for cannabis cultivation and handling licence with a view to producing cannabis suitable for medicinal use.

Cannabis cultivated under the development scheme cannot be used in the pilot programme and may therefore not be given to patients.

The purpose of the development scheme is to give companies that have been granted a licence under the scheme, the option of cultivating, developing and testing medicinal cannabis, in order for a uniform and standardised product to be achieved over time, having the quality needed for the product to form part of the medicinal cannabis pilot programme.

Medical cannabis under the development scheme can be sold/handed over to others who are authorised for processing and development under the development scheme. Medical cannabis under the development scheme may also be exported for analysis purposes.

Status

In 2018, there was a total of 1,211 citizens in Denmark who presented a prescription of at least one cannabis product under the pilot programme.

At present, four companies have been granted a licence to produce cannabis intermediate products for the pilot programme, and yet five other companies have applied for a license and their applications are currently subject to processing with the Danish Medicines Agency. Two companies have been granted a licence for the production of cannabis bulk and four other companies have applied for a license and their applications are currently subject to processing with the Danish Medicines Agency.

Currently, more than 30 companies have been granted a licence for the cultivation and handling of cannabis with a view to developing cannabis for medicinal use.

Do you require more information?

Our next newsletter will take a closer look at the various licence types which your company can apply for. If you require any further information on the pilot programme and the development scheme, you are of course welcome to approach one of our specialists who will be ready to assist you.