CBD as a narcotic in Italy: what does the new government decree provide?

Published on June 27th in the Gazzetta Ufficiale, the decree approved by the Italian government inserted CBD preparations for oral use in section B of the medicines table. But what does this mean and why is it so serious? With this decree, Italy will be one of the few countries in Europe to treat CBD as a medicine, limiting sales only to pharmacies with a prescription (as in Portugal), and putting all activities in the sector into crisis. Sector associations and traders still hope that this new attempt will be yet another time, unfeasible until the end of this month.

According to new decree, the Italian government published that “considered, for the above, in light of the new opinions expressed by the Higher Institute of Health and the Higher Health Council, of having to proceed with the issuance of a new decree which, due to the renewed investigation, determines the inclusion of compositions for oral administration of cannabidiol obtained from Cannabis extracts in Table B of medicines referred to in decree of the President of the Republic no. 309 of 1990, while revoking the ministerial decrees of October 1, 2020, October 28, 2020 and August 7, 2023.

Decrees:

Article 1

1. In the medicines table, section B, of the decree of the President of the Republic of October 9, 1990, n. 309 and following modifications, the following phrase is inserted in alphabetical order: compositions for oral administration of cannabidiol obtained from Cannabis extracts.
2. From the date of entry into force of this decree, the ministerial decrees of October 1, 2020, October 28, 2020 and August 7, 2023 are revoked.
3. This decree enters into force on the thirtieth day following its publication in the Official Journal of the Italian Republic. Rome, 27 June 2024

The Minister: Schillaci”

Despite the intentions of the Italian government, the Canapa Sativa Italia Association (CSI) warns that “the decree only concerns oral CBD compositions intended for medicinal purposes”. Consequently, “cosmetic products containing CBD and other hemp derivatives are not considered in this restriction, continuing to be legal and available on the market, without the need for a medical prescription”.

Narcotic CBD: Italian decree violates EU regulations
The Italian government's attempt to include CBD in the medicines table went against the ruling of the European Court of Justice, which in 2020 said: “CBD cannot be considered a narcotic”, because “it does not result in psychotropic effects or harmful effects on human health.”

A historic phrase, whose value centers on this statement: “A member state [of the EU] cannot view the commercialization of cannabidiol (CBD) legally produced in another member state, if it is extracted from the Cannabis sativa plant in its entirety and not just of its fibers and seeds.”

Furthermore, as mentioned by the CSI, “the decree was not notified to TRIS (Technical Regulation Information System), the European Union system that contains all member states to notify new technical regulations before their adoption. This omission represents a further violation of EU procedure, which aims to guarantee the transparency and coherence of member states’ rules.”

To conclude, also reporting a recommendation from the World Health Organization (WHO), also citing the decree approved by the government, which in 2020 invited all member states not to include CBD-based products with THC up to 0,2 in this table. %.