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.

As of September 2021, the Ministry of Health has finally provided clarifications for companies that aims to grow Cannabis Sativa L. from certified seeds of varieties permitted under European law for the purpose of supplying pharmaceutical companies authorised by the Italian Medicines Agency (AIFA) to manufacture active pharmaceutical ingredients (API). The grower intending to apply for the authorisation shall enter into an agreement to supply the leaves and inflorescences to a pharmaceutical company authorised to produce API. The grower can in fact sell his product only to that company. The Ministry has specified that the agreement, which is an essential requirement for the authorisation, must be signed by the date of submission of the cultivation and manufacturing applications. The application must also include detailed information on the cultivation activity, such as the species and variety, an estimate of the quantity to be produced annually, an indication of the place of cultivation as well as those used for processing and storage of the product ready for sale to the pharmaceutical company.

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.

As of September 2021, the Ministry of Health clarified that, upon authorization, industrial cannabis may be cultivated for the purpose of supplying pharmaceutical companies authorised to manufacture active pharmaceutical ingredients (API).  

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. Cosmetics with CBD are marketable in Italy if they are in accordance with the requirements of Regulation (EC) No 1223/2009 on cosmetic products. Therefore, the cosmetic product may not contain narcotics as listed in Table I and II of the UN Single Convention on narcotic drugs (1961). 

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 4 April 2022, the Ministry of Defence published a notice with the aim of selecting companies able to cultivate cannabis plants to be supplied to the Military Chemical and Pharmaceutical Plant in Florence for the manufacture of medicines and pharmaceutical raw materials. Please note that the Ministry reserves the right to suspend or not proceed with the identification of interested partners. The selection will not bind the Authority to launch any procedure.
The selection of the economic operators who have expressed interest will take place through four phases:

  1. qualitative selection of candidates
  2. technical inspection and assessment of suitability
  3. confirmation of the expression of interest and transmission of invitations to the restricted procedure;
  4. start-up of the experiment with final evaluation and suitability assessment of the economic operators.
Portrait of Laura Opilio
Laura Opilio
Partner
Rome
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Maria Letizia Patania
Counsel
Rome
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Roberto Plutino
Associate
Milan