On 15 December 2017, the Danish Parliament adopted by unanimous vote a new Act on a pilot scheme on cannabis for medicinal use (the “Cannabis Act”).
The scheme will be introduced on 1 January 2018. In anticipation of the final adoption of the Act, the Danish Medicines Agency (DMA) began in October 2017 to accept applications for authorisation to import and/or manufacture cannabis-containing substances for medicinal use. One company authorisation has been issued, and six more are pending.
The scheme primarily concerns cannabis products imported from EEA member states, and separate, parallel legislation provides for the growing of cannabis for medicinal use in Denmark.
The imported products must have been legally grown and distributed in the exporting country. Two products imported from the Netherlands were approved on 21 December 20171.
The declared purpose of the Act is to allow a four-year trial period to gather experience and possibly sufficient documentation to establish a permanent regime or to issue, upon application, an ordinary (bibliographic) marketing authorisation.
More telling is the wish by the legislature to respond to repeated requests for legalising the supply and treatment of patients with medicinal cannabis under regulated circumstances, which was not possible under the previously existing legislation. Cannabis is an euphoriant substance, and although it is not illegal to prescribe it “off label”, doing so involves both a professional as well as a legal risk and the distribution of it is a criminal offence. At the same time, scientific opinions differ as to the advantages and risks, and since intellectual property protection is not available, there is no or little interest among traditional pharmaceutical companies in investing in the robust clinical trial documentation that would be required under the Danish Medicines Act and Directive 2001/83/EC on the Community code relating to medicinal products for human use (the Human Medicines Directive). (There is one product containing cannabis oil2 that holds an ordinary MA.)
By enacting special legislation allowing the importation and sale of medicinal cannabis under regulated circumstances, the legislator has found a way of responding which meets the various concerns. The legislation is inspired by similar arrangements in or on the way in some (albeit still only few) other EU countries.
Medicinal cannabis products authorised under the new Act will technically not be finished medicinal products holding a Marketing Authorisation (MA), but will rather be primary or intermediate products which can be legally transformed into finished legal medicinal products by being prescribed by a physician to an individual patient.
The DMA website contains a guide for manufacturers and importers on how to apply for authorisation to import primary products or intermediate products and/or to manufacture imported primary products into intermediate products, and how to obtain registration of a products. There will be a special listing of approved products, and the regulatory requirements for labelling, packet inserts, pricing, reporting, etc. will be the same as those for other medicinal products, and for each level of distribution there will be quality requirements and inspections as is the case for other manufacturing or distribution licenses. In addition, the Act contains many separate requirements to take account of the nature of the product; however, the overall picture is that the Cannabis Act largely mirrors the Danish Medicines Act.
The Human Medicines Directive restricts the freedom of the Member States to approve medicinal products without strictly following the harmonised system laid down in the Directive. However, the pilot scheme is designed to fall within the exemption contained in Article 5.1. of the Directive as interpreted in case C-185/10 Commission v. Poland3. The Act is carefully drafted to take account of the criteria set by the said provision, e.g. by designating products as intermediate even though in practice they are in finished form, and the Act also includes an absolute prohibition of advertising, which is a logical prohibition as the Human Medicines Directive strictly prohibits advertising for products that do not have an MA. The Act does not prohibit advertising for health care services which may include a claim of “experience with cannabis treatment”.
The medicinal cannabis pilot scheme is inspired by arrangements in the Netherlands and Germany for the medicinal use of cannabis.