The legal qualification of CBD-based products is one of the most debated issues in the Italian cannabis legislation. The regulatory framework only provides precise indications with reference to the content of THC while it is silent with respect to CBD.
Authored By: Laura Opilio
Laura Opilio
Partner CMS Adonnino Ascoli & Cavasola Scamoni
00184 Rome
Italy
The legal qualification of CBD-based products is one of the most debated issues in the Italian cannabis legislation. The regulatory framework only provides precise indications with reference to the content of THC while it is silent with respect to CBD.
On this regard it is worth noting that the Decree of the President of the Republic no. 309 of 1990 includes cannabis sativa among the narcotic substances whose cultivation, possession, use and processing must be expressly authorized by the Ministry of Health.
The same Decree also establishes that cannabis-based medicinal products will be subject to a partially different regulation compared to ordinary medicinal products. In fact, such products shall comply with additional authorization requirements in respect to those prescribed for medicines that do not contain narcotic substances. By way of example, the storage facility shall receive a specific authorization from the Ministry of Health, whereas the Ministry does not normally intervene in the authorization process of medicines which is instead managed by AIFA (Agenzia Italiana del Farmaco).
The regulatory framework concerning the use of THC is influenced by the application of two additional legislative texts. At first, it is worth mentioning Law No. 242 of 2016 which, in order to encourage the cultivation of hemp for industrial use, has provided a special hypothesis of exclusion of punishability for those growers who cultivate hemp of the permitted varieties listed in the Common Catalogue of Varieties of Agricultural Plant Species, pursuant to Article 17 of Council Directive 2002/53/EC of 13 June 2002. Accordingly, the growers who cultivate hemp of the above mentioned qualities are not punishable if the total THC content of the cultivation is higher than 0,2% and within the limit of 0,6%.
Finally, it is worth mentioning that recently, by a decree of 4 November 2019, published on 15 January 2020, the limits of THC in foods have been set. The allowed foods are hemp seeds, flour obtained from hemp seeds, oil obtained from hemp seeds and supplements containing hemp-derived foods. For all these products the percentage of THC allowed ranges from 2.0 to 5.0 mg/Kg.
Turning our attention to CBD, it is evident that all the above mentioned regulations do not contain any reference to this substance, whose use does not seem to be regulated in detail. This has caused in the last years a bit of confusion on the market where many hemp based products with a low level of THC, but still containing CBD, have been introduced.
These products obtained from the so-called cannabis light have been the subject of a series of decisions of the Italian Supreme Court, which with the judgment of the Joint Chambers of last 19 May 2019 clarified that the marketing of leaves, inflorescences, oil and resin obtained from industrial hemp with low THC content still constitutes a violation of the law, unless such derivatives are concretely devoid of any doping or psychotropic effect.
However, the Supreme Court has not established the parameters through which it is possible to determine the psychotropic effect, therefore increasing the uncertainty of the market players.
Such uncertainty has not actually characterized the Italian market alone, but the EU market as a whole, requiring the intervention of the Court of Justice of the European Union which recently ruled on 19 November 2020 in Case C-663/18 (Kanavape). By this decision the CJEU stated that CBD is not mentioned in either the Convention on Psychotropic Substances or the Single Convention on Narcotic Drugs to which the European Union law makes reference in order to define the terms drug or narcotic drug.
Furthermore, the Court affirmed that a Member State may not prohibit the marketing of cannabidiol lawfully produced in another Member State when it is extracted from the Cannabis sativa plant in its entirety and not solely from its fiber and seeds. This position seems to be comforted by the WHO which is inclined to support the thesis that products containing CBD and with THC levels below 0.2% should not be included in any list of psychotropic substances.
As far as Italy is concerned, due to the absence of a specific regulation, the only reference was a Note dated 2 October 2008 issued by the Central Narcotics Office of the Ministry of Health in which it was stated that CBD should not be considered a narcotic substance as THC, although being a product with a recognized pharmacological activity which could therefore be used for the production of drugs following the standard procedures for obtaining the MA.
Recently, on 15 October 2020 the Italian Ministry of Health issued a decree including “compositions for oral administration of cannabidiol obtained from Cannabis extracts” into the list of medicines containing narcotic and psychotropic substances as of 31 October.
In the preamble of this decree, the Ministry states that the decision is motivated by the circumstance that the compositions for oral administration of cannabidiol obtained from cannabis extracts are used in the treatment of epilepsy and that is currently being evaluated by the Italian Medicines Agency an application for marketing authorization of a drug in oral solution containing cannabidiol, which has already received the centralized marketing authorization by the European Medicines Agency.
The decision of the Ministry would also be supported by two scientific opinions, respectively by the Superior Health Council and the Superior Health Institute. In these opinions the latter advisory bodies of the Ministry of Health expressed a favorable opinion on the inclusion of CBD among controlled drugs, although noting that the regulatory authorities of Spain, Germany and France have also expressed their opinion on the subject stating that CBD-based medicines should not be included in the list of controlled drugs.
On 28 October the same Ministry suspended the above decree stating that further in-depth scientific studies were necessary. The decision to suspend the inclusion of these preparations in the list of narcotic substances seems to be in line with the most recent opinions of European authorities on the matter and seems to have been welcomed by market players. At the same time, however, it should not be forgotten that the absence of a clear position from the Italian Ministry of Health on what are the precise boundaries within which the use of CBD is considered to be legitimate continues to heavily influence the market, on which a high degree of uncertainty remains both on the part of the controllers and the ones controlled.
