UN Officially Recognises the Medicinal Properties of Cannabis

• Cannabis has been removed from Schedule IV of the 1961 Single Convention, the list reserved for the most dangerous and addictive substances with no therapeutic value.
  

• Cannabidiol (CBD) preparations remain in legal limbo, as they could be brought under international control at any time.

After two years of waiting, with meetings between States, technical reports, multilateral negotiations, lobbying, European bureaucracy and internal debate, the long-awaited day finally came and the recommendations of the World Health Organization were put to the vote at the Commission on Narcotic Drugs in Vienna, the United Nations’ policy-making body on drugs. 2 December 2020 will undoubtedly be remembered as a historic day: the beginning of the end of the prohibition of medical cannabis. However, as so often when decriminalising the plant is on the table, the vote was bittersweet.

On the one hand, a fundamental change was approved: cannabis was removed from Schedule IV of the 1961 Single Convention, the list reserved for the most dangerous and addictive substances with no therapeutic potential. The decision was extremely close, with 27 votes in favour and 25 against, the global prohibitionist bloc being led by China, Russia, Turkey, Chile and Brazil, still anchored in the positions of 1961. The measure amounts to an express recognition of the medicinal properties of cannabis at United Nations (UN) level, and it allows Member States to justify programmes giving patients access to medical cannabis. This is great news for millions of patients who currently obtain cannabis informally and unsafely. We hope that States will act consistently with the new legal status of cannabis and introduce medical cannabis regulation without further delay. Despite this step forward for medical cannabis and for patients’ rights and freedoms, not everything was good news. In its recommendation 5.5 the World Health Organization had proposed that preparations of pure cannabidiol (CBD) containing less than 0.2% THC should not be subject to international control. This proposal was based purely on technical grounds, following a review of CBD by the WHO Expert Committee on Drug Dependence, the UN’s advisory body on these matters, which concluded that cannabidiol is neither dangerous nor addictive and has therapeutic potential. To implement the recommendation, the WHO proposed adding a footnote to Schedule I of the 1961 Single Convention on Narcotic Drugs. The proposal was rejected by a wide margin, so cannabidiol, which is not currently under international control, could be scheduled in the future if States decide to control it and add it to one of the schedules.

 

A key court ruling for the European CBD market

Following the rejection of WHO recommendation 5.5, cannabidiol preparations remain in legal limbo, as they could be brought under control at any time. Until that happens, however, European producers and sellers have some breathing space thanks to the recent ruling of the Court of Justice of the European Union (CJEU) of 19 November. In this judgment, delivered in response to a request for a preliminary ruling from a French court of appeal concerning the marketing in France of cannabidiol imported from the Czech Republic, where it had been lawfully produced from authorised industrial hemp crops, the CJEU, following the Advocate General’s opinion, held that Member States cannot restrict the sale of imported CBD products made from the whole industrial hemp plant, so it is irrelevant that they do not come only from the parts of the plant not controlled by the international conventions (stalks, roots and seeds).

The CJEU found that, since CBD is not controlled under the international conventions and comes from authorised industrial hemp crops, it cannot be considered a narcotic drug. The ruling also relies on the scientific evidence showing that CBD has no dangerous or harmful effects on health, as the World Health Organization has stated, and that there are no public health grounds justifying a restriction on the free movement of goods within the European market, as France had argued in order to limit its sale. Other points stand out in the judgment, such as the finding that cannabidiol (CBD) cannot be considered an agricultural product, which means its sale does not fall under the EU rules on industrial hemp. Above all, the CJEU departs from the prohibitionist position held until now by the national medicines agencies of most EU countries, including the Spanish Agency of Medicines and Medical Devices (AEMPS). The AEMPS argued that, because extracts of the plant are controlled under the international conventions and CBD is obtained by extraction, its production, processing and sale required a prior AEMPS licence. The CJEU rejected this view and looked at the intention of the drafters, concluding that if they had wanted to control CBD, it would have been expressly listed in the conventions, just as THC is.

 

Developments at the European Commission

The ruling has already prompted a reaction from the European Commission. In January 2019 CBD was added to the Novel Food Catalogue and, since then, it has required extensive testing and authorisation by food safety authorities before it can be included in products and marketed as food in the Member States. In July this year the Commission, the EU’s executive branch, said it had stopped assessing pre-market authorisation applications for CBD products while it decided whether CBD should be regulated as a narcotic. After the CJEU ruling, on Wednesday 2 December the Commission sent a statement to the European Industrial Hemp Association and to at least one other novel food applicant (the novel food application process had been suspended until then) revising its initial position and stating that hemp-derived cannabidiol should not be regulated as a narcotic and can therefore qualify as food. The Commission cited last month’s Court of Justice ruling, which held that CBD derived from the whole hemp plant is not a narcotic drug under international drug treaties and is therefore covered by EU law on the free movement of goods between Member States. The Commission’s full statement to novel food applicants reads: “In view of the comments received from the applicants and the recent judgment of the Court in Case C-663/18, the Commission has revised its preliminary assessment and concludes that cannabidiol should not be considered a drug within the meaning of the 1961 United Nations Single Convention on Narcotic Drugs in so far as it does not have a psychotropic effect. Consequently, cannabidiol can qualify as food, provided that the other conditions of Article 2 of Regulation (EC) No 178/2002 are also met.” This decision is a huge relief for the European industrial hemp and CBD industry. It reassures processors and manufacturers of food, food supplements and edible CBD products that they no longer face the prospect of a general ban on the EU market, and it gives legal certainty to a sector set to grow exponentially in the coming years, creating a multi-million-euro market and thousands of jobs. In addition, seizures of CBD-based products should stop immediately, provided they come from EU-authorised varieties. This position opens the door to claims by processors, intermediaries and retailers whose cannabidiol products have been seized and who face court proceedings, so that their rights are restored, their products returned and the proceedings dismissed.

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