New decision from the Court of Justice of the European Union and publication of report on the assessment of the medicinal cannabis pilot programme.
The Court of Justice of the European Union's decision in the case C-663/18 (Kanavape)
On 19 November 2020, the Court of Justice of the European Union ("CJEU") ruled in the case C-663/18 (Kanavape) regarding a reference for a preliminary ruling on whether a French law prohibiting the marketing of products containing Cannabidiol (CBD) extracted from hemp was contrary to EU law.
Firstly, the CJEU established that CBD is not included under the definition of "drugs", nor can it be classified as a "narcotic drug" under the United Nations' Single Convention on Narcotic Drugs of 30 March 1961, even though CBD is extracted from the entirety of the hemp and not just its seeds and fibre, if the tetrahydrocannabinol (THC) content does not exceed 0.2%.
The CJEU found it important that CBD does not appear to have any psychotropic effect or any harmful effect on human health on the basis of available scientific data.
Secondly, the CJEU found that since CBD is not a drug, CBD is comprised by the rules on the free movement of goods in Articles 34 and 36 TFEU.
The CJEU also found that the French prohibition on the marketing of CBD extracted from hemp constituted measures having equivalent effect to quantitative restrictions within the meaning of Article 34 TFEU. Such restrictions can be justified on one of the grounds of public interest laid down in Article 36 TFEU. Additionally, the measure must be appropriate for securing the attainment of the objective pursued and must not go beyond what is necessary in order to attain it.
The French government had claimed that the objective of the prohibition against marketing of CBD extracted from hemp was to protect public health. In this respect, the CJEU said that such restrictions can be justified on the grounds of public interest.
However, the CJEU found that the restriction did not secure the attainment of the objective pursued, as the French prohibition did not extend to the marketing of synthetic CBD which has the same properties as CBD extracted from hemp and could be used as a substitute for the latter. On this basis, the CJEU declared that the French prohibition was contrary to EU law.
What impact does this ruling have on Danish law?
In general, Danish law complies with EU law, as under Danish law CBD is not considered a drug if its THC content does not exceed 0.2 % pursuant to Section 1(3)(vii) of the Danish statutory order on drugs.
Potentially, the ruling could have an impact on how the Danish authorities assess products containing CBD extracted from hemp, as it is clear from the guidelines of the Danish Environmental Protection Agency that the use of CBD is not allowed in cosmetics if the CBD in question has been made from hemp extracts, tinctures or resin, see the Danish Environmental Protection Agency's guidelines on CBD in cosmetics (in Danish).
Read the judgment of the CJEU
The Ministry of Health's assessment of the medicinal cannabis pilot programme
On 30 November 2020, the Ministry of Health published its report on the assessment of the medicinal cannabis pilot programme.
In general, the Ministry of Health concludes that the pilot programme has provided the healthcare system with a safe setting for using medicinal cannabis, but also that there are still significant challenges facing the current programme. For instance, the Ministry says that it is necessary to collect more evidence regarding the positive effects of cannabis, and whether such effects compensate for the negative effects of cannabis. It also points out that it is a problem that there are very few medicinal products on the Danish market, especially because the current products are relatively expensive, and doctors are reluctant to prescribe these products to their patients.
The report contains a number of suggestions, like for instance increasing the reimbursement for medicinal products containing cannabis; providing doctors with more guidelines allowing them to feel comfortable about prescribing these medicinal products; and reconsidering the Danish rules on the production of medicinal cannabis in order to make the Danish production of medicinal cannabis more competitive compared to the production in other European countries.
Read the report of the Danish Ministry of Health (in Danish)