artikel | 26 nov 2019

Questions remain regarding classification of CBD products

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The Swedish Medical Products Agency (MPA) considers that products containing cannabidiol (CBD) for oral use or inhalation constitute medicinal products according to the Medicinal Products Act, and that such products must therefore be approved in order to be sold. Recently, several marketing bans on such products were examined by the Administrative Court. The bans remain in place, but the court’s reasoning raises questions about the classification of the products.

The plant Cannabis sativa (hemp) contains several different active substances (cannabinoids), two of which are tetrahydrocannabinol (THC) and cannabidiol (CBD). THC gives hallucinogenic effects, whereas CBD does not have those properties. THC is covered by drug legislation and the MPA is of the opinion that CBD is covered by medicinal products legislation.

In Sweden, there is currently only one approved medicinal product containing cannabis extract. The product is a mouth spray that can be prescribed to patients suffering from multiple sclerosis to relieve symptoms related to muscle stiffness. Occasionally, cannabis-based drugs are also prescribed under licence, and the media reports that the number of licence applications is increasing.

It is against this background that the MPA decided in 2018 that, in order to be allowed to be sold, products containing CBD taken orally or inhaled must be approved as medicinal products. The products were sold as food supplements, and the companies concerned appealed the decision of the MPA to the Administrative Court, which has now reviewed the matter.

The Swedish Medical Products Act stipulates that a product can be a medicinal product by function or by designation/presentation. The MPA argued that the products were to be regarded as medicinal products, both by their function and by how they were presented. This was what the court was asked to rule upon.

A product is a medicinal product by function if it may be used on or administered to humans with the view to restoring, correcting or modifying physiological functions through pharmacological, immunological or metabolic action, or for making a diagnosis. In support of its conclusion that this was the case with the products in question, the MPA stated inter alia that the products contain CBD, which is one of two active substances in the above-mentioned approved medicinal product, and that it is likely that the effect of the medicinal product is partly due to its CBD content. However, since the approved medicinal product in question also contains the active substance THC, the Administrative Court considered that this did not support in any decisive way the products having the relevant properties and constituting medicinal products by function.

The MPA also referred to another medicinal product that is approved in the US and that contains CBD as its active substance. As the MPA did not provide any detailed information on content and dosage, they were also unable to support the claim that the products in question in the case are medicinal products by function.

In addition, the MPA referred to a study regarding treatment with CBD preparations, but the Administrative Court found that the study involved a far greater intake of CBD than the recommended use of the relevant products would entail.

The Court concluded that there was no reason to question that CBD in itself has properties that are likely to lead to beneficial effects on human health, but the documentation invoked by the MPA was not sufficient for it to be considered likely that the products in question have such effect in the body that they can prevent or treat disease. All in all, the MPA had not made probable that the products constitute medicinal products by function.

The Administrative Court therefore proceeded to examine whether the products constituted medicinal products by presentation, i.e. if they included information about them having properties to prevent or treat disease in humans. The various operators had marketed the products in question in slightly different ways, but common to all the operators was that they stated, or in different ways suggested, that the products were recommended for or could be effective against certain diseases. In this context, the Administrative Court considered how the potential buyer perceives the product and, in many cases, considered it very likely that the buyer perceives products containing CBD as medicinal products. The products were thus considered to be medicinal products by presentation.

Neither of the judgements have been appealed, and to this date three out of five have been upheld. The MPA states that the Administrative Court has now made it clear that CBD oils are medicinal products. We believe that this is too general a conclusion to draw from the judgements of the Administrative Court. The MPA’s documentation regarding the products’ function as medicinal products was rejected by the court. However, in one way or another, all the products had been marketed as medicinal products, and it was on these grounds they were considered to be medicinal products. We do not know what the outcome would have been if the court had also examined a CBD product that had not been marketed with medical claims.

We are keeping a close eye on the developments in the area.



Life Sciences

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