Cannabis law and legislation in Italy

Medical use

Growing, selling and importing medical cannabis is allowed on the condition that the authorisation of the Ministry of Health is obtained. Cultivation, sale and import are currently mainly managed by the state through internal production, import from the Netherlands or public tenders for the supply.

Authorisation by the Ministry of Health is mandatory. Such authorisation is personal and cannot be sold or transferred. Moreover, it can be granted only to institutions or companies whose owner or legal representative, if they are companies, is of good behaviour and offers moral and professional guarantees.

Cannabis-based medicines which are already authorised in Italy can be prescribed to patients by physicians using a special form approved by the Ministry of Health. If the medicinal product is not authorised in Italy but duly authorised in a foreign country, the Italian doctor is required to send a request to the Ministry of Health and to the competent customs office for the importation of the medicine in Italy. The request must include the special needs that justify the use of the unauthorised medicine, in the absence of a valid therapeutic alternative. In addition, physicians may also prescribe magistral preparations with cannabis-based plant products, which are generally prepared by specialized pharmacies. Such preparations can be made from legally imported cannabis, or from the domestic production of cannabis for medical use at the Stabilimento Chimico Farmaceutico Militare in Florence.

Anyone who, without the authorisation, imports, exports, purchases, receives or holds medicines containing narcotic or psychotropic substances, which exceed the prescribed quantity, may be sanctioned with imprisonment from six to twenty years and with a fine of EUR 26,000 to EUR 260,000. The aforementioned penalties can be reduced by a third to a half in specific circumstances.

Recreational use

In Italy it is not permitted to sell cannabis for recreational use.

However, some companies have chosen to market a product with low THC content whose sale is permitted based on industrial cannabis legislation only. In short, in the Italian market, “recreational cannabis” is essentially “cannabis for industrial use”, which however, not being a smoke product, is sold with the explicit warning “product not for human use” - “do not smoke”.

Industrial use

Cannabis can be used for industrial purposes on the condition that the THC is lower than 0.2%. However, in accordance with law no. 242 of 2016, if, as a result of a control by the authorities, the total THC content of is more than 0.2% but no more than 0.6%, no liability shall be borne by the grower.

Industrial cannabis can be used for: (a) foods and cosmetics; (b) semi-finished products, such as fibre, powders, oils or fuels; (c) material intended for use as green manure; (d) organic material for bioengineering works or products useful for green building; (e) material aimed at phytodepuration for the remediation of polluted sites; (f) crops dedicated to teaching and demonstration activities as well as research by public or private institutions; and (g) crops intended for floriculture.

The only sanctions currently provided by the law on industrial cannabis are the seizure or destruction of the cannabis if the THC content in cultivation is higher than 0.6% .

The law does not provide for sanctions related to the marketing of industrial cannabis, which must be derived from the general legislation on product safety and consumer protection. If, on the other hand, a farmer grows cannabis without authorisation that does not fall within the definition of “industrial cannabis”, they may be punished with imprisonment of six to twenty years and fined from EUR 26,000 to EUR 260,000.

There is no proper regulation on CBD in Italy. CBD is a substance with recognised pharmacological activity that is not included in the table of drugs. The Ministry of Health has explained that if the CBD is used for the production of medicines, not being present in the tables of narcotic or psychotropic substances, the current legislation on medicinal products should be applied. As a consequence, the rules on medicinal products containing psychotropic substances, which applies to THC, cannot be applied to CBD.

As far as the use of CBD in food and food supplements is concerned, this substance is considered a novel food and therefore requires a specific authorization by the European Commission according to EU Regulation 2015/2283. Therefore, to date, CBD cannot be considered to be an ingredient that can be used in food supplements in Italy.

The Italian regulations do not prevent CBD from being used as an ingredient in cosmetics. However, it is appropriate to consider that the use of cannabidiol (CBD) in cosmetics is harmonised within the European Cosmetic Regulation 1223/2009. The regulation prohibits the use of cannabis and cannabis extracts in cosmetics. The European Commission added two entries to its database of cosmetics ingredients (CosIng) for cannabidiol to differentiate between CBD “derived from extract or tincture or resin of cannabis” and “CBD synthetically produced”. Both the entries provide that “Cannabidiol (CBD) as such, irrespective of its source, is not listed in the Schedules of the 1961 Single Convention on Narcotic Drugs. However, it shall be prohibited from use in cosmetic products (II/306), if it is prepared as an extract or tincture or resin of Cannabis in accordance with the Single Convention. Please note that national legislations on controlled substances may also apply.”

Accordingly, the use of naturally derived CBD from cannabis plant is prohibited but the use of synthetically produced CBD is allowed. In addition, the Single Convention’s banned ingredients list does not include cannabis seeds or leaves without tops, meaning the use of CBD derived from these parts of the cannabis plant is not currently prohibited. 

Patentability

There is no specific prohibition on patenting a cannabis-based product, provided that the commercial exploitation of the invention does not infringe any law and is not contrary to public order.

Latest developments

On 15 October 2020, the Ministry of Health published a Decree stating that “compositions for oral administration of cannabidiol obtained from Cannabis extracts” should have been included within the List of Medicines containing narcotic and psychotropic substances according to Presidential Decree no. 309/1990.

Nevertheless, by a subsequent Decree of 28 October 2020, the above Decree has been suspended on the grounds that inclusion of compositions for the oral administration of cannabidiol obtained from Cannabis extracts within the list of narcotic/psychotropic substances requires further in-depth, technical and scientific studies, which are entrusted to the National Institute of Health (Istituto Superiore di Sanità) and National Council of Health (Consiglio Superiore di Sanità).

Therefore, the entry into force of the CBD Decree is currently suspended pending the pronouncement of the Istituto Superiore di Sanità and the Consiglio Superiore di Sanità.

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Laura Opilio
Partner
Rome
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Maria Letizia Patania
Counsel
Rome
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Roberto Plutino
Associate
Milan