We recently reviewed the law on cannabis-based medicines. It is clear that changes in scientific data and social attitudes mean that producers are faced with rapid evolution and differences in regulatory approach between countries, not only for medicines but for other products too.
E-cigarettes containing CBD illegal in France
A French case currently before the European court is highlighting the issues around the use of cannabis derivatives in consumer products.
The product under review is an e-cigarette including cannabidiol in the liquid formulation. Cannabidiol, or CDB, is a non-psychoactive compound derived from Cannabis sativa, or hemp plants. In contrast, tetrahydrocannabinol (THC) is the compound derived from cannabis plants that produces psychotropic effects and so it is much more tightly controlled.
The CBD used in the e-cigarette liquid is produced in the Czech Republic, using the whole hemp plant, and then imported into France. Under French law, only the fibre and seeds of the hemp plant can be grown and commercialised, and only using varieties with a THC content of 0.20% or less. Production of CBD from fibre and seeds alone is not a realistic option, and so the ban on whole-plant products effectively means that plant-derived CBD oil cannot be imported or sold in France.
The importers of the CBD for the e-cigarette were prosecuted and received criminal convictions for commercialising the illegal CBD. This conviction was challenged before the European court on the basis that the French legislation was contrary to EU law.
Is this against EU law?
EU Treaty obligations (TFEU Art. 34 and 36) require member states to permit the free movement of goods across the bloc. There are some exceptions to the free movement rule – one of which involves national restrictions that are justified by the need to protect human health.
The current stage of the case sees the Advocate General giving an opinion to guide the court in its decision-making. The opinion makes interesting reading.
The AG’s view is that the law restricting the import of CBD oil into France is a restriction on the free movement of goods cross-border. Justification on the basis of protecting human health could be allowed but only
“if that measure is appropriate for securing the achievement of the objective pursued and does not go beyond what is necessary in order to attain it”.
The French Government had cited studies indicating that there could be adverse reactions to CBD, such as drowsiness, lethargy, ataxia, psychiatric disorders and liver disease. It also pointed to the lack of scientific certainty regarding the harmful effects of CBD. This, the French Government said, justified their restrictive position under the precautionary principle.
The AG did not say outright that the French Government’s approach was illegal, but in his opinion the French courts should be asked to reconsider
- whether CBD oil in e-cigarettes does really present a risk to human health on the basis of available scientific evidence, and
- whether the blanket ban in French law goes beyond what is really necessary to protect human health, or whether a less restrictive measure could be adopted, such as a maximum CBD content.
Additional arguments raised by the CBD importers based on EU medicinal products legislation were dismissed for procedural reasons. And the AG was not persuaded by arguments based on specific EU regulations applying to agricultural products.
What next?
The European court is not obliged to follow the AG’s opinion, although it does usually do so. We will have to wait until later in the year for a final result.
In the meantime, the AG opinion offers some encouragement to businesses commercialising products including CBD within the EU. We can expect to see a greater degree of consistency between the laws that apply in different EU member states.
This article was written by Medilink EM Patron, Mills and Reeve LLP.